Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-16 @ 9:38 AM
Study NCT ID:
NCT02789358
Status:
COMPLETED
Last Update Posted:
2019-08-15
First Post:
2016-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Time-to-effect Based Dosing Strategy in Cryoballoon Ablation of Patients With Paroxysmal Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000255', 'term': 'Adenosine Triphosphate'}], 'ancestors': [{'id': 'D000227', 'term': 'Adenine Nucleotides'}, {'id': 'D011685', 'term': 'Purine Nucleotides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-14', 'studyFirstSubmitDate': '2016-05-17', 'studyFirstSubmitQcDate': '2016-06-01', 'lastUpdatePostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atrial fibrillation-free survival, without antiarrhythmic drug therapy', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Mean number of cryotherapy applications per patient to complete isolation', 'timeFrame': 'Intraprocedural'}, {'measure': 'Total cryotherapy time', 'timeFrame': 'Intraprocedure', 'description': 'Total cryotherapy time of applications needed per patient'}, {'measure': 'Time required to complete isolation of all the pulmonary veins (LA time)', 'timeFrame': 'Intraprocedure', 'description': 'Time from the end of transeptal approach until the withdrawal of the cryoballoon'}, {'measure': 'Total procedure time', 'timeFrame': 'Intraprocedure', 'description': 'Time from the local anesthesia is administrated until the whole procedure is finished'}, {'measure': 'Acute reconnection of pulmonary veins', 'timeFrame': 'Intraprocedure', 'description': 'Number of veins reconnected after a 30 minutes waiting period since the end of procedure and with adenosine test'}, {'measure': 'Adverse events', 'timeFrame': 'Intraprocedure', 'description': 'Number of participants with procedural-related adverse events as assessed by by CTCAE v4.0'}, {'measure': 'Total number of atrial fibrillation episodes monitored by Nuubo system', 'timeFrame': '12 Months'}, {'measure': 'Total time in atrial fibrillation monitored by Nuubo system', 'timeFrame': '12 months', 'description': 'Total time in atrial fibrillation monitored by Nuubo system in hours'}, {'measure': 'Atrial fibrillation burden detected by Nuubo system', 'timeFrame': '12 Months', 'description': 'total time in atrial fibrillation related to the hole time of monitoring (percentage)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cryotherapy'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '29247029', 'type': 'DERIVED', 'citation': 'Ferrero-de-Loma-Osorio A, Garcia-Fernandez A, Castillo-Castillo J, Izquierdo-de-Francisco M, Ibanez-Criado A, Moreno-Arribas J, Martinez A, Bertomeu-Gonzalez V, Lopez-Mases P, Ajo-Ferrer M, Nunez C, Bondanza-Saavedra L, Sanchez-Gomez JM, Martinez-Martinez JG, Chorro-Gasco FJ, Ruiz-Granell R. Time-to-Effect-Based Dosing Strategy for Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation: Results of the plusONE Multicenter Randomized Controlled Noninferiority Trial. Circ Arrhythm Electrophysiol. 2017 Dec;10(12):e005318. doi: 10.1161/CIRCEP.117.005318.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to validate a new dosage of cryotherapy based on time to effect in pulmonary vein ablation procedures in patients with paroxysmal atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with at least 2 documented episodes of paroxysmal Atrial Fibrillation (AF) which are not responders to at least one antiarrythmic drug\n\nExclusion Criteria:\n\n* Previous left atrial ablation procedure or surgery\n* left atrium diameter \\> 50mm\n* presence of intracardiac thrombus\n* Left ventricular ejection fraction \\< 40%\n* Heart failure class III-IV\n* Severe valvulopathies\n* Acute coronary syndrome or cardiac surgery within the previous 3 months of enrollment\n* Transient ischemic attack/stroke within the previous 6 months of enrollment\n* life expectancy less than 1 year\n* Any contraindication to the procedure according to the current clinical practice'}, 'identificationModule': {'nctId': 'NCT02789358', 'acronym': 'plusONE', 'briefTitle': 'A Time-to-effect Based Dosing Strategy in Cryoballoon Ablation of Patients With Paroxysmal Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para la Investigación del Hospital Clínico de Valencia'}, 'officialTitle': 'A Time-to-effect Based Dosing Strategy in Cryoballoon Ablation of Patients With Paroxysmal Atrial Fibrillation. Results of the the plusONE Randomized Multicenter Trial', 'orgStudyIdInfo': {'id': 'FIHCValencia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm', 'description': 'Conventional protocol for cryoablation:\n\nAt least 2 applications of 180s each', 'interventionNames': ['Other: Conventional cryotherapy dosage', 'Device: Arctic Front Advance ST Cryoenergy Balloon Catheter', 'Drug: Adenosine triphosphate', 'Device: nECG platform Nuubo®']}, {'type': 'EXPERIMENTAL', 'label': 'Study Arm', 'description': 'Experimental protocol for cryoablation:\n\nTime to effect + 1 minute and a bonus application of 120s', 'interventionNames': ['Other: Experimental cryotherapy dosage', 'Device: Arctic Front Advance ST Cryoenergy Balloon Catheter', 'Drug: Adenosine triphosphate', 'Device: nECG platform Nuubo®']}], 'interventions': [{'name': 'Conventional cryotherapy dosage', 'type': 'OTHER', 'description': 'Cryotherapy dosage: 180 seconds applications until block of the pulmonary vein plus 1 bonus freezing of 180 seconds', 'armGroupLabels': ['Control Arm']}, {'name': 'Experimental cryotherapy dosage', 'type': 'OTHER', 'description': 'cryotherapy dosage: applications "time to block of the vein" plus 60 seconds long until block of the vein plus 1 bonus freezing of 120 seconds', 'armGroupLabels': ['Study Arm']}, {'name': 'Arctic Front Advance ST Cryoenergy Balloon Catheter', 'type': 'DEVICE', 'description': 'Electrical isolation of pulmonary veins with Arctic Front Advance cryoballoon', 'armGroupLabels': ['Control Arm', 'Study Arm']}, {'name': 'Adenosine triphosphate', 'type': 'DRUG', 'description': '12 mg of adenosine triphosphate are administrated intravenously to test dormant conduction in pulmonary veins apparently disconnected', 'armGroupLabels': ['Control Arm', 'Study Arm']}, {'name': 'nECG platform Nuubo®', 'type': 'DEVICE', 'description': '30 days electrocardiographic monitoring system to detect atrial fibrillation episodes after ablation', 'armGroupLabels': ['Control Arm', 'Study Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Ángel Ferrero De Loma-Osorio, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiologist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación para la Investigación del Hospital Clínico de Valencia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD-PhD', 'investigatorFullName': 'Angel Ferrero', 'investigatorAffiliation': 'Fundación para la Investigación del Hospital Clínico de Valencia'}}}}