Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
Study NCT ID:
NCT02074566
Status:
COMPLETED
Last Update Posted:
2020-03-12
First Post:
2014-02-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-10', 'studyFirstSubmitDate': '2014-02-10', 'studyFirstSubmitQcDate': '2014-02-27', 'lastUpdatePostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients wit successfull pulmonary vein isolation', 'timeFrame': 'up to 6 minutes', 'description': 'Assessment of successfull pulmonary vein isolation after 2 x 1/2/3 minutes of cryoballoon application. The assessment of this outcome will take place during the procedure.'}], 'secondaryOutcomes': [{'measure': 'Number of complications', 'timeFrame': '1 year', 'description': 'Complications being:\n\n1. Phrenic nerve palsy or diminishment of diaphragm excursion during cryo-ablation.\n2. Temperatures reaching \\<12 C in the oesophagus during cryoablation.\n3. Other complications such as delayed gastric emptying, pericardial fluid/tamponade, haemoptoe, vascular complications.'}, {'measure': 'Patients in which acute success of pulmonary vein isolation (after 1 freezing cycle) was present', 'timeFrame': 'up to 6 minutes', 'description': 'The assessment of this outcome will take place during the procedure'}, {'measure': 'Duration of thaw phase (= time between end of freezing to automatic deflation of the balloon) related to acute success of pulmonary vein isolation', 'timeFrame': 'up to 6 minutes', 'description': 'The assessment of this outcome will take place during the procedure.'}, {'measure': 'Procedure time, fluoroscopy time, amount of contrast used', 'timeFrame': 'up to 6 minutes', 'description': 'The assessment of this outcome will take place right after the procedure. It measures procedural parameters.'}, {'measure': 'Lower Esophageal Temperature development', 'timeFrame': 'up to 6 minutes', 'description': 'The measurement will take place during the procedure. It registrates the lower esophageal temperature ande the development during the course of the procedure.'}, {'measure': 'Atrial Fibrillation recurrence', 'timeFrame': 'after 1 year follow up'}, {'measure': 'Balloon temperatures measured by the console', 'timeFrame': 'up to 6 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary Vein Isolation', 'Atrial fibrillation', 'Cryoballoon therapy', 'Duration'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Therefore it is of utmost importance to define the optimal duration of cryoballoon ablation time.The objective of the study is to assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.', 'detailedDescription': 'Rationale Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Therefore it is of utmost importance to define the optimal duration of cryoballoon ablation time.\n\nObjective To assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.\n\nStudy design The study is designed as a prospective multicentre randomized efficacy study.\n\nStudy population Patients 18-70 years of age with paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.\n\nIntervention Patients will be randomized to 2 cycles of 1, 2 or 3 minutes of cryoballoon ablation after reaching the temperature "plateau phase".\n\nMain study parameters/endpoints Acute success of pulmonary vein isolation.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness:\n\nNo additional risk is present as the procedure is common clinical practice, current cryoballoon application time is 3 minutes Shorter application times are not expected to add to the risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.\n* Age \\< 70 years.\n* Willing and able to sign informed consent.\n* Willing to and capable of following the requested study procedures.\n\nExclusion Criteria:\n\n* Age \\< 18 years.\n* Pregnancy\n* Life or follow-up expectancy \\< 12 months.\n* Previous PVI.\n* Contrast allergy.\n* Creatin clearance level \\< 60.\n* Left ventricular ejection fraction \\< 40%\n* Abnormal left atrium anatomy defined as number of PV's ≠ 4 or Left Atrium diameter \\>50mm (measured in the parasternal long axis, as assessed with transthoracic echocardiography) or \\>40 cc/m2 . This will lead to exclusion after inclusion but before randomisation."}, 'identificationModule': {'nctId': 'NCT02074566', 'briefTitle': 'Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study', 'organization': {'class': 'OTHER', 'fullName': 'Thorax Centrum Twente'}, 'officialTitle': 'A Prospective Randomized Multicentre Efficacy Study on Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study', 'orgStudyIdInfo': {'id': 'NL47337.044.13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '2 times 1', 'description': 'PVI will be performed using a cryoballoon ablation application time of 2 times 1 minute', 'interventionNames': ['Other: Cryoballoon ablation']}, {'type': 'OTHER', 'label': '2 times 2', 'description': 'PVI will be performed using a cryoballoon ablation application time of 2 times 2 minutes', 'interventionNames': ['Other: Cryoballoon ablation']}, {'type': 'OTHER', 'label': '2 times 3', 'description': 'PVI will be performed using a cryoballoon ablation application time of 2 times 3 minutes', 'interventionNames': ['Other: Cryoballoon ablation']}], 'interventions': [{'name': 'Cryoballoon ablation', 'type': 'OTHER', 'description': 'PVI using cryoballoon', 'armGroupLabels': ['2 times 1', '2 times 2', '2 times 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500 KA', 'city': 'Enschede', 'state': 'Nederland', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'zip': '6229 HX', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Centre', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harald Verheij', 'class': 'OTHER'}, 'collaborators': [{'name': 'Thorax Centrum Twente', 'class': 'OTHER'}, {'name': 'Academisch Ziekenhuis Maastricht', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Drs.', 'investigatorFullName': 'Harald Verheij', 'investigatorAffiliation': 'Thorax Centrum Twente'}}}}