Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-20 @ 3:15 PM
Study NCT ID:
NCT03204695
Status:
TERMINATED
Last Update Posted:
2024-04-23
First Post:
2017-06-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
WAVECREST Post Market Clinical Follow-Up (PMCF) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Senior Director Clinical Research', 'organization': 'Coherex Medical, Inc.'}, 'certainAgreement': {'otherDetails': 'Results of this clinical study may be submitted for publication without regard for whether the trial results are positive or negative. Sponsor will be responsible for oversight of the publication process and will have oversight of publications of results of the trial, the Physician Advisory Committee may advise.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline up to 45 days', 'description': "The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein. Baseline was defined as the last available measurement on or before the date of the implantation procedure.", 'eventGroups': [{'id': 'EG000', 'title': 'Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System', 'description': 'In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 6, 'seriousNumAtRisk': 24, 'deathsNumAffected': 2, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Cardiac aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Device embolization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Pneumococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Arterial injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System', 'description': 'In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.'}], 'classes': [{'title': 'All-cause mortality', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Pericardial effusion requiring intervention', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Device embolization (major)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Device thrombus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ischemic stroke', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to 45 days', 'description': 'The primary safety outcome was the composite of death from any cause (all-cause mortality), pericardial effusion requiring intervention, device embolization (major), device thrombus and ischemic stroke up to 45 days. The analysis was based on Sponsor Assessment of Adverse Events data. Baseline was defined as the last available measurement on or before the date of the implantation procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Device Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System', 'description': 'In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline up to 45 days', 'description': 'Percentage of participants who achieved device success were reported. Device success was defined as the percentage of participants who had the device deployed and implanted in the correct position. Baseline was defined as the last available measurement on or before the date of the implantation procedure.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System', 'description': 'In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline up to 45 days', 'description': 'Percentage of participants who achieved technical success were reported. Technical success was defined as the percentage of participants who experienced successful placement and release of the occluder in the LAA with LAA closure (defined as no leak greater than \\[\\>\\]5 millimeters \\[mm\\] on color Doppler transesophageal echocardiogram \\[TEE\\]) and who were discharged from the cardiac catheterization laboratory without the occurrence of device-related complications. Baseline was defined as the last available measurement on or before the date of the implantation procedure.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System', 'description': 'In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline up to 45 days', 'description': 'Percentage of participants who achieved procedural success were reported. Procedural success was defined as the percentage of participants who experienced successful placement and release of the occluder in the LAA with LAA closure (defined as no leak \\>5 mm on color Doppler TEE) and who were discharged from the cardiac catheterization laboratory without device-related complications and without procedure-related complications other than minor device embolization (defined as device embolization that can be resolved by percutaneous technique without surgical intervention or damage to surrounding cardiovascular structures). Baseline was defined as the last available measurement on or before the date of the implantation procedure.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System', 'description': 'In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Treated: Intent-to-treat (ITT) Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Participant was treated with another device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System', 'description': 'In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.8', 'spread': '7.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': "The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-17', 'size': 1439166, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-26T06:00', 'hasProtocol': True}, {'date': '2022-07-05', 'size': 1298546, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-26T06:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'whyStopped': 'Study closed due to device design modifications.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2017-06-16', 'resultsFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2017-06-28', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-26', 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint)', 'timeFrame': 'From baseline up to 45 days', 'description': 'The primary safety outcome was the composite of death from any cause (all-cause mortality), pericardial effusion requiring intervention, device embolization (major), device thrombus and ischemic stroke up to 45 days. The analysis was based on Sponsor Assessment of Adverse Events data. Baseline was defined as the last available measurement on or before the date of the implantation procedure.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved Device Success', 'timeFrame': 'From baseline up to 45 days', 'description': 'Percentage of participants who achieved device success were reported. Device success was defined as the percentage of participants who had the device deployed and implanted in the correct position. Baseline was defined as the last available measurement on or before the date of the implantation procedure.'}, {'measure': 'Percentage of Participants Who Achieved Technical Success', 'timeFrame': 'From baseline up to 45 days', 'description': 'Percentage of participants who achieved technical success were reported. Technical success was defined as the percentage of participants who experienced successful placement and release of the occluder in the LAA with LAA closure (defined as no leak greater than \\[\\>\\]5 millimeters \\[mm\\] on color Doppler transesophageal echocardiogram \\[TEE\\]) and who were discharged from the cardiac catheterization laboratory without the occurrence of device-related complications. Baseline was defined as the last available measurement on or before the date of the implantation procedure.'}, {'measure': 'Percentage of Participants Who Achieved Procedural Success', 'timeFrame': 'From baseline up to 45 days', 'description': 'Percentage of participants who achieved procedural success were reported. Procedural success was defined as the percentage of participants who experienced successful placement and release of the occluder in the LAA with LAA closure (defined as no leak \\>5 mm on color Doppler TEE) and who were discharged from the cardiac catheterization laboratory without device-related complications and without procedure-related complications other than minor device embolization (defined as device embolization that can be resolved by percutaneous technique without surgical intervention or damage to surrounding cardiovascular structures). Baseline was defined as the last available measurement on or before the date of the implantation procedure.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Non-valvular atrial fibrillation', 'Atrial Fibrillation', 'Stroke', 'Left Atrial Appendage (LAA)', 'LAA Closure', 'LAA Occlusion', 'WaveCrest'], 'conditions': ['Non-valvular Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System in the current medical practice setting in patients with non-valvular atrial fibrillation who are at increased risk for stroke. Up to 65 subjects may be enrolled at up to 15 study sites in Europe. Patients will be followed through 45 days post-procedure.', 'detailedDescription': 'The Coherex WaveCrest® Left Atrial Appendage Occlusion System is designed to permanently occlude the Left Atrial Appendage (LAA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The criteria for implant are in accordance to the current version of the Instructions for Use:\n\nInclusion Criteria:\n\n1. Non-valvular paroxysmal, persistent, or permanent atrial fibrillation\n2. 18 years of age or older\n3. LAA anatomy amenable to treatment by percutaneous techniques\n4. Risk factors for potential thrombus formation in the LAA\n5. Willing to participate in the required follow-up visits and tests\n6. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee or Institutional Review Board at the study site\n\nExclusion Criteria:\n\n1. Known contraindication to percutaneous transseptal intervention\n2. Left atrial appendage anatomy or size that will not allow appropriate implantation of the WaveCrest Implant\n3. Intracardiac thrombus or other cardiac abnormality visualized prior to implant that would significantly impact procedural safety\n4. Mitral valve stenosis \\< 1.5 cm2 or any stenosis consistent with rheumatic valvular disease or history of mitral valve replacement or repair\n5. Known contraindication and/or allergy to nickel\n6. Known active bacterial infection (i.e., sepsis, endocarditis)\n7. Any known medical condition or overall health of the subject that could adversely affect procedural safety or potentially prevent the patient from completing all study required visits and tests.\n8. Pregnant or breastfeeding women due to the risk of exposure to x-rays and medications associated with the implant procedure.'}, 'identificationModule': {'nctId': 'NCT03204695', 'briefTitle': 'WAVECREST Post Market Clinical Follow-Up (PMCF) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coherex Medical'}, 'officialTitle': 'A Prospective, Multicenter, Non-randomized, Post-market Clinical Follow-up Study to Confirm Safety and Performance of the Coherex WaveCrest® Left Atrial Appendage Occlusion System in Patients With Non-valvular Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'CHX_IP015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WaveCrest®', 'description': 'Implant of WaveCrest® Left Atrial Appendage Occlusion System', 'interventionNames': ['Device: Percutaneous LAA Closure', 'Drug: Anticoagulation or Clopidogrel']}], 'interventions': [{'name': 'Percutaneous LAA Closure', 'type': 'DEVICE', 'description': 'LAA Closure with the WaveCrest LAA Occlusion System (study device)', 'armGroupLabels': ['WaveCrest®']}, {'name': 'Anticoagulation or Clopidogrel', 'type': 'DRUG', 'description': 'Subjects either continue on anticoagulation or receive clopidogrel', 'armGroupLabels': ['WaveCrest®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalst', 'country': 'Belgium', 'facility': 'OLV Hospital', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}], 'overallOfficials': [{'name': 'Tom De Potter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OLV Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Site-specific clinical study results may be published by Investigators in compliance with the Investigator Agreement and/or site agreement, as applicable.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coherex Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}