Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-03-01 @ 12:21 AM
Study NCT ID:
NCT03347227
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2017-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of Arrhythmia Substrate to Ablate Persistent 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': 'D017115', 'term': 'Catheter Ablation'}], 'ancestors': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single-blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, parallel arm randomized clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 502}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2017-11-15', 'studyFirstSubmitQcDate': '2017-11-16', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of documented (>30s) AF, atrial flutter or atrial tachycardia occuring from day 91 to 18 months post ablation', 'timeFrame': 'day 91 post ablation to 18 months', 'description': 'Documented AF, Aflutter or AT by ECG, holter or external loop monitoring and has a duration of at least 30 seconds'}], 'secondaryOutcomes': [{'measure': 'AF burden', 'timeFrame': 'At 12 months and 18 months', 'description': 'Documented amount of AF'}, {'measure': 'Need for repeat ablation procedure for AF, AFl or AT', 'timeFrame': 'Up to 18 months', 'description': 'Documented by ECG, holter or ECG loop recorder'}, {'measure': 'Need for emergency room visits or hospitalization', 'timeFrame': 'Up to 18 months', 'description': 'Hospital admission for \\> 24 hours and emergency room admission'}, {'measure': 'Incidence of any ECG documented AF with 90 days of ablation', 'timeFrame': 'up to 90 days', 'description': 'Symptomatic or asymptomatic AF'}, {'measure': 'Time to first recurrence at 18 months according to sex and atrial scar extent', 'timeFrame': '18 months', 'description': 'Recurrence of AF, AFl or AT'}, {'measure': 'Composite safety outcome', 'timeFrame': 'Up to 18 months', 'description': 'Procedure related complications at any time (stroke, PV stenosis, pericarditis, cardiac perforation, major bleeding) and/or death'}, {'measure': 'Total ablation delivery time', 'timeFrame': 'Day of ablation procedure', 'description': 'RF ablation time'}, {'measure': 'Total procedure duration', 'timeFrame': 'Day of ablation procedure', 'description': 'Start of ablation to end of ablation'}, {'measure': 'Quality of life analyses', 'timeFrame': '18 months', 'description': 'Using EQ-5D general quality of life score, and AF severity scale (symptoms and functionality)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AF ablation', 'Pulmonary vein isolation', 'Atrial scar ablation'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'A multicentre, parallel group, two arm, single-blinded randomized clinical trial, assessing the efficacy of a patient-tailored catheter ablation (CA) strategy guided by atrial scar mapping in addition to pulmonary vein isolation (PVI) when compared to PVI alone in patients with persistent atrial fibrillation (AF).', 'detailedDescription': 'The optimal CA strategy for persistent AF remains unknown. Current data highlight the need for a better understanding of the substrate and mechanisms of arrhythmia maintenance in this population. Atrial scar-based catheter ablation has recently emerged as a promising strategy for ablation of AF. However, the available data has limitations that preclude definitive conclusions regarding the utility of this strategy (no data from multicenter, randomized studies available). Further research is needed to assess the role of scar-based ablation for persistent AF.\n\nThe Investigators hypothesize that catheter ablation of persistent AF (PeAF) tailored to abolish abnormal atrial substrate identified by intracardiac atrial scar mapping in addition to pulmonary vein isolation (PVI) will result in higher procedural success rates when compared to PVI alone.\n\nThe study will recruit 502 patients with PeAF (251 per treatment arm) who are candidates for CA ablation of AF according to the treating physician (and in agreement with current practice guidelines). Subjects will be recruited over a 42 month period. The total duration of the study is 60 months.\n\nPrior to undergoing catheter ablation subjects will be seen by the investigator/ research assistant and the following data will be collected:\n\ni. Age and sex ii. Structural heart disease if present iii. CHADS2VASc score iv. DR-FLASH score v. NYHA class vi. Current medications vii. Duration of uninterrupted AF viii. Height and weight ix. Echocardiogram and other cardiac imaging results (within previous 12 months, including assessment of left ventricular ejection fraction, left atrial volume and valve function) x. ECG, Holter or loop monitor recording (within past 36 months) documenting AF.\n\nSubjects will be randomly assigned in a 1:1 ratio to undergo wide area circumferential ablation for pulmonary vein isolation (PVI- control arm) or wide area circumferential ablation PVI and scar ablation (experimental arm). Randomization will be stratified by centre and by sex. Subjects will be randomized prior to the procedure.\n\nEnrolled subjects will have a clinical follow-up visit at 3, 6, 12 and 18 months after the ablation procedure. A 14-day continuous ambulatory ECG monitor will be completed at each visit. The results of monitoring will be interpreted at a centralized core lab, and the results will be adjudicated by an arrhythmia specialist blinded to treatment group. A total of three questionnaires will be administered throughout the study, each at a specific time point. The Quality of Life (EQ-5D), CCS-Severity of AF scale, and Atrial Fibrillation Effect on Quality of life (AFEQT) will be completed at baseline, and at the 12-month and 18 month visit.\n\nConcomitant medical therapy will be selected according to the treating physician. All subjects will be maintained on systemic oral anticoagulation for at least 2 months following catheter ablation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years ;\n2. Subjects with symptomatic persistent AF AND clinically indicated catheter ablation for AF\n3. At least one episode of AF that is sustained beyond 3 months in duration ; documented on 12-lead ECG, Holter monitor, loop monitor or trans-telephonic monitor (TTM) within 36 months of enrollment in the study;\n4. Modified DR-FLASH score \\>=4\n\n4\\. Subjects must be able to provide informed consent.\n\nExclusion Criteria:\n\n1. History of previous catheter ablation for AF or left atrial flutter;\n2. History of previous surgical ablation for AF;\n3. Known intracardiac thrombus;\n4. Contraindication to systemic oral anticoagulation therapy;\n5. Reversible causes of AF;\n6. Hypertrophic cardiomyopathy;\n7. Severe valvular disease (mitral/aortic stenosis or regurgitation);\n8. Subjects that are pregnant or breastfeeding;\n9. Comorbid condition with life expectancy \\< 1 year'}, 'identificationModule': {'nctId': 'NCT03347227', 'acronym': 'COAST-AF RCT', 'briefTitle': 'Characterization of Arrhythmia Substrate to Ablate Persistent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Heart Institute Research Corporation'}, 'officialTitle': 'Characterization of Arrhythmia Substrate to Ablate Persistent Atrial Fibrillation (Coast-AF) Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '20170'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pulmonary Vein Isolation', 'description': 'Wide area circumferential catheter ablation for pulmonary vein isolation', 'interventionNames': ['Procedure: Catheter ablation']}, {'type': 'EXPERIMENTAL', 'label': 'Pulmonary Vein Isolation and scar ablation', 'description': 'Wide area circumferential catheter ablation for pulmonary vein isolation and scar ablation', 'interventionNames': ['Procedure: Catheter ablation']}], 'interventions': [{'name': 'Catheter ablation', 'type': 'PROCEDURE', 'otherNames': ['Atrial Fibrillation Ablation'], 'description': 'Wide area circumferential catheter ablation for pulmonary vein isolation of persistent atrial fibrillation', 'armGroupLabels': ['Pulmonary Vein Isolation', 'Pulmonary Vein Isolation and scar ablation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'George Veenhuyzen, MD', 'role': 'CONTACT'}, {'name': 'George Veenhuyzen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Libin Cardiovascular Institute', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jason Andrade, MD', 'role': 'CONTACT'}, {'name': 'Jason Andrade, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'John Sapp, MD', 'role': 'CONTACT'}, {'name': 'John Sapp, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'QEII Health Sciences Centre, Nova Scotia Health Authority', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jorge Wong, MD', 'role': 'CONTACT'}, {'name': 'Jorge Wong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'London', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Allan Skanes, MD', 'role': 'CONTACT'}, {'name': 'Allan Skanes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L3Y 2P9', 'city': 'Newmarket', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Atul Verma, MD', 'role': 'CONTACT'}, {'name': 'Atul Verma, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southlake Regional Health Centre', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'K1Y 4W7', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Pablo Nery, MD', 'role': 'CONTACT', 'email': 'pnery@ottawaheart.ca', 'phone': '613-696-7272'}, {'name': 'David Birnie, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pablo Nery, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Paul Angaran, MD', 'role': 'CONTACT'}, {'name': 'Paul Angaran, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Derek Yung, MD', 'role': 'CONTACT'}, {'name': 'Derek Yung, Md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rouge Valley Regional Heart Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2W 1T8', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jean-Marc Raymond, MD', 'role': 'CONTACT'}, {'name': 'Jean-Marc Raymond, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Centre Hospitalier de l'Universite de Montreal (CHUM)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mario Sturmer, MD', 'role': 'CONTACT'}, {'name': 'Mario Sturmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sacre-Coeur Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Vidal Essebag, MD', 'role': 'CONTACT'}, {'name': 'Jacqueline Joza, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Laurent Macle, MD', 'role': 'CONTACT'}, {'name': 'Laurent Macle, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Isabelle Nault, MD', 'role': 'CONTACT'}, {'name': 'Isabelle Nault, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute Universitaire de Cardiologie et Pneumologie du Quebec (IUCPQ)', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Charles Dussault, MD', 'role': 'CONTACT'}, {'name': 'Charles Dussault, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CIUSSS de L'Estrie-CHUS-Hopital Fleurimont", 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'centralContacts': [{'name': 'Pablo Nery, MD', 'role': 'CONTACT', 'email': 'pnery@ottawaheart.ca', 'phone': '613-696-7272'}, {'name': 'Tammy Knight', 'role': 'CONTACT', 'email': 'tknight@ottawaheart.ca', 'phone': '613-696-7000', 'phoneExt': '19080'}], 'overallOfficials': [{'name': 'Pablo Nery, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Heart Institute Research Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Heart Institute Research Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart and Stroke Foundation of Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}