Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-01-04 @ 12:14 AM
Study NCT ID:
NCT02830360
Status:
COMPLETED
Last Update Posted:
2024-08-01
First Post:
2016-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antiarrhythmics or Ablation for Ventricular Tachycardia 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000638', 'term': 'Amiodarone'}, {'id': 'D013015', 'term': 'Sotalol'}, {'id': 'D017115', 'term': 'Catheter Ablation'}], 'ancestors': [{'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 416}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2016-07-07', 'studyFirstSubmitQcDate': '2016-07-11', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '8 years (including pilot study data)', 'description': 'Time to any death occurring at any time post randomization'}, {'measure': 'Appropriate ICD shock at least 14 days post randomization', 'timeFrame': '8 years (including pilot study data)', 'description': 'Time to first appropriate ICD shock after 14 days post randomization'}, {'measure': 'VT storm at least 14 days post randomization', 'timeFrame': '8 years (including pilot study data)', 'description': 'Time to 3 or more episodes of VT within 24 hours'}, {'measure': 'Sustained VT requiring treatment at least 14 days post randomziation', 'timeFrame': '8 years (including pilot study data)', 'description': 'Time to any sustained VT greater below the detection rate of the ICD requiring cardioversion (electrical or chemical) or manual ICD therapy at least 14 days post randomization'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality at any time', 'timeFrame': '8 years (including pilot study data)', 'description': 'Time to any death occurring at any time post randomization'}, {'measure': 'Appropriate ICD ATP at any time or after 14 days', 'timeFrame': '8 years (including pilot study data)', 'description': 'any appropriate therapy delivered from the ICD at least 14 days post randomization'}, {'measure': 'Appropriate shocks at any time or after 14 days', 'timeFrame': '8 years (including pilot study data)', 'description': 'appropriate ICD shocks at any time post randomization'}, {'measure': 'VT storm at any time or after 14 days', 'timeFrame': '8 years (including pilot study data)', 'description': '3 or more episodes of VT occurring within 24 hours at any time post randomization; including incessant VT'}, {'measure': 'Sustained VT not treated by ICD at any time or after 14 days', 'timeFrame': '8 years (including pilot study data)', 'description': 'any sustained VT greater than 30 seconds captured on a rhythm strip, monitor zone, holter monitor, or 12 lead ECG'}, {'measure': 'Time to sustained VT treated with appropriate any type of manual cardioversion after 14 days', 'timeFrame': '8 years (including pilot study data)', 'description': 'Any sustained VT greater than 30 seconds requiring manual cardioversion (ICD, external or pharmacologic)'}, {'measure': 'Inappropriate ICD shocks at any time or after 14 days', 'timeFrame': '8 years (including pilot study data)', 'description': 'all inappropriate shocks from the ICD at any time post randomization'}, {'measure': 'Any ICD shock at any time or after 14 days', 'timeFrame': '6 years (including pilot study data)', 'description': 'Both appropriate and inappropriate shocks from the ICD at any time post randomization'}, {'measure': 'Any ventricular arrhythmia event at any time or after 14 days (composite of appropriate ATP, appropriate shock, sustained VT not treated by ICD, external cardioversion, or pharmacologic cardioversion)', 'timeFrame': '8 years (including pilot study data)', 'description': 'All ventricular arrhythmias including a composite of: appropriate ATP, appropriate shock, sustained VT not treated by ICD, external cardioversion, or pharmacologic cardioversion), VT storm/incessant VT.'}, {'measure': 'Number of ICD shocks (all cause)', 'timeFrame': '8 years (including pilot study data)', 'description': 'the number of all shocks from any cause will be calculated'}, {'measure': 'Number of Anti-tachycardia pacing (ATP)', 'timeFrame': '8 years (including pilot study data)', 'description': 'The total of all ATP delivered from the ICD will be calculated'}, {'measure': 'Number of ICD appropriate therapy', 'timeFrame': '8 years (including pilot study data)', 'description': 'Total number of therapies which received appropriate ICD therapy'}, {'measure': 'Number of VT storm events', 'timeFrame': '8 years (including pilot study data)', 'description': 'Total number of VT storms (3 episodes of VT within 24 hours)/ incessant VT will be calculated'}, {'measure': 'Number of sustained VT events', 'timeFrame': '8 years (including pilot study data)', 'description': 'Total number of sustained VT (greater than 30 seconds)'}, {'measure': 'Number of ventricular arrhythmia events', 'timeFrame': '8 years (including pilot study data)', 'description': 'This is a composite of appropriate ATP, appropriate shock, sustained VT not treated by ICD, external cardioversion, or pharmacologic cardioversion, or VT storm/incessant VT. VT events which do not terminate despite exhausting ICD therapies will be considered incessant VT and included within the definition of VT storm.'}, {'measure': 'Hospital admission for cardiac causes', 'timeFrame': '8 years (including pilot study data)', 'description': 'Hospitalizations greater than 24 hours due to a cardiovascular cause.'}, {'measure': 'Ablation procedural complications or antiarrhythmic drug adverse effects (this may require a separate substudy, depending on data complexity)', 'timeFrame': '8 years (including pilot study data)', 'description': 'Periprocedural complications and adverse drug reactions will be assessed'}, {'measure': 'Serious adverse events', 'timeFrame': '8 years (including pilot study data)', 'description': 'Serious events is any event which causes death, hospitalization, is life threatening and is directly related to the study treatment.'}, {'measure': 'Side effects from anti-arrhythmic medication', 'timeFrame': '8 years (including pilot study data)', 'description': 'Any dose change or discontinuation of anti-arrhythmic medication due to abnormal blood tests (including kidney function, liver function, thyroid function) or any perceived side effects.'}, {'measure': 'Quality of life - SF36', 'timeFrame': '8 years (including pilot study data)', 'description': 'Will include responses from the Short Form 36'}, {'measure': 'Quality of life - EQ5D', 'timeFrame': '8 years (including pilot study data))', 'description': 'Will include responses from the Euroquol 5D questionnaire'}, {'measure': 'Quality of life - HADS', 'timeFrame': '8 years (including pilot study data)', 'description': 'Will include responses from the Hospital Anxiety and Depression Scale quesionnaire'}, {'measure': 'Cost-effectiveness', 'timeFrame': '8 years (including pilot study data)', 'description': 'Quality adjusted life years (QALYs) will be derived from the case report forms and the questionnaires'}, {'measure': 'Escalation and De-escalation of antiarrhythmic medication', 'timeFrame': '8 years (including pilot study data)', 'description': 'Any increase or decrease in the dosage of antiarrhythmic medication either due to inefficacy or side effects will be assessed.'}, {'measure': 'ICD Revision', 'timeFrame': '8 years (including pilot study data)', 'description': 'Surgical revisions to implanted defibrillators at any time'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Antiarrhythmic drug therapy', 'VT Catheter ablation', 'ICD Therapy', 'Ischemic Heart Disease'], 'conditions': ['Ventricular Tachycardia (VT)']}, 'referencesModule': {'references': [{'pmid': '41217320', 'type': 'DERIVED', 'citation': 'Nery PB, Wells GA, Tang ASL, Parkash R, Stevenson W, Healey JS, Gula L, Nair GM, Essebag V, Rivard L, Deyell MW, Sarrazin JF, Amit G, Roux JF, AbdelWahab A, Lane C, Samuel M, Sandila N, Sapp JL; VANISH2 Study Team. Catheter Ablation vs Sotalol or Amiodarone for Ventricular Tachycardia: A Substudy of the VANISH2 Trial. J Am Coll Cardiol. 2025 Oct 11:S0735-1097(25)09522-1. doi: 10.1016/j.jacc.2025.09.1595. Online ahead of print.'}, {'pmid': '39555820', 'type': 'DERIVED', 'citation': 'Sapp JL, Tang ASL, Parkash R, Stevenson WG, Healey JS, Gula LJ, Nair GM, Essebag V, Rivard L, Roux JF, Nery PB, Sarrazin JF, Amit G, Raymond JM, Deyell M, Lane C, Sacher F, de Chillou C, Kuriachan V, AbdelWahab A, Nault I, Dyrda K, Wilton S, Jolly U, Kanagasundram A, Wells GA; VANISH2 Study Team. Catheter Ablation or Antiarrhythmic Drugs for Ventricular Tachycardia. N Engl J Med. 2025 Feb 20;392(8):737-747. doi: 10.1056/NEJMoa2409501. Epub 2024 Nov 16.'}, {'pmid': '38649085', 'type': 'DERIVED', 'citation': 'Sapp JL, Tang ASL, Parkash R, Stevenson WG, Healey JS, Wells G. A randomized clinical trial of catheter ablation and antiarrhythmic drug therapy for suppression of ventricular tachycardia in ischemic cardiomyopathy: The VANISH2 trial. Am Heart J. 2024 Aug;274:1-10. doi: 10.1016/j.ahj.2024.04.009. Epub 2024 Apr 21.'}, {'pmid': '31698933', 'type': 'DERIVED', 'citation': 'Kheiri B, Barbarawi M, Zayed Y, Hicks M, Osman M, Rashdan L, Kyi HH, Bachuwa G, Hassan M, Stecker EC, Nazer B, Bhatt DL. Antiarrhythmic Drugs or Catheter Ablation in the Management of Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007600. doi: 10.1161/CIRCEP.119.007600. Epub 2019 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'A multicenter, randomized clinical trial to assess whether catheter ablation or antiarrhythmic drug therapy provides the most effective control of important clinical outcomes for patients with prior myocardial infarction and sustained monomorphic ventricular tachycardia (VT).', 'detailedDescription': "Implantable Defibrillators (ICDs) reduce sudden death and can terminate some VT without shocks, but they don't prevent VT; the most appropriate strategy to suppress VT remains unknown. Two randomized clinical trials have suggested that catheter ablation can significantly reduce the incidence of subsequent VT in patients after an initial episode. Neither trial, however, compared catheter ablation to active antiarrhythmic drug therapy. Randomized trials of antiarrhythmic drug therapy have demonstrated that therapy with either sotalol or amiodarone can reduce recurrent VT. Both antiarrhythmic drug and ablation therapy suffer from imperfect efficacy and the potential for significant side-effects. No study has compared ablation to drug therapy for first-line treatment. The VANISH study which compared ablation to aggressive antiarrhythmic drug therapy for patients who have failed initial drug therapy was published in May 2016, and demonstrated that for patients with drug-refractory VT, catheter ablation was superior to escalation of antiarrhythmic drug therapy. Benefits were seen in the group which had VT despite amiodarone. Event rates were similar between amiodarone and sotalol for patients with VT occurring despite sotalol, who were randomized to either new initiation of amiodarone or catheter ablation. These results do not address the clinical question of the most appropriate first line therapy for suppression of VT in persons with prior myocardial infarction, an ICD and VT.\n\nThe trial hypothesis is: catheter ablation will, in comparison to antiarrhythmic drug therapy reduce the composite outcome of death at any time, appropriate ICD shock after 14 days, ventricular tachycardia storm after 14 days or treated sustained ventricular tachycardia below the detection rate of the ICD for patients with prior myocardial infarction and sustained monomorphic ventricular tachycardia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prior Myocardial Infarction and\n* One of the following VT events while not being treated with amiodarone, sotalol, or another class I or class III antiarrhythmic drug) within the last 6 months:\n\n * Sustained monomorphic VT documented on 12-lead ECG or rhythm strip terminated by pharmacologic means or DC cardioversion\n * ≥3 episodes of VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic\n * ≥ 5 episodes of VT treated with antitachycardia pacing (ATP) regardless of symptoms\n * ≥1 appropriate ICD shocks,\n * ≥3 VT episodes within 24 hours\n\nExclusion Criteria:\n\n* Unable or unwilling to provide informed consent.\n* Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug-induced arrhythmia), had recent acute coronary syndrome within 30 days, coronary revascularization (\\<90 days bypass surgery, \\<30 days percutaneous coronary intervention), or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia.\n* Are ineligible to take the antiarrhythmic drug to which they would be assigned due to allergy, intolerance or contraindication\n* Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves\n* Have had a prior catheter ablation procedure for VT\n* Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF)\n* Are in renal failure (Creatinine clearance \\<15 mL/min), have NYHA Functional class IV heart failure, or a systemic illness likely to limit survival to \\<1 year\n* Have had recent ST elevation myocardial infarction or non-ST elevation MI (\\< 30 days); note that biomarker elevation alone after ventricular arrhythmias does not denote MI.\n* Are pregnant.'}, 'identificationModule': {'nctId': 'NCT02830360', 'acronym': 'VANISH2', 'briefTitle': 'Antiarrhythmics or Ablation for Ventricular Tachycardia 2', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'Ventricular Tachycardia Antiarrhythmics or AblatioN In Structural Heart Disease 2', 'orgStudyIdInfo': {'id': 'SAPP004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'VT catheter ablation', 'description': 'Catheter ablation of ventricular tachycardia', 'interventionNames': ['Procedure: Catheter ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Antiarrhythmic Drug Therapy', 'description': "Patients will be prescribed either oral amiodarone or sotalol daily (dosage and frequency to be determined based on patient's clinical presentation at the time of the qualifying arrhythmia).", 'interventionNames': ['Drug: Antiarrythmic Drug Therapy']}], 'interventions': [{'name': 'Antiarrythmic Drug Therapy', 'type': 'DRUG', 'otherNames': ['Amiodarone (Cordarone) or Sotalol (Sotacor)'], 'description': 'Patients will be prescribed antiarrhythmic drugs (either amiodarone or sotalol based on specific clinical presentation, including medical history, functional class, ejection fraction, and renal function.)', 'armGroupLabels': ['Antiarrhythmic Drug Therapy']}, {'name': 'Catheter ablation', 'type': 'PROCEDURE', 'otherNames': ['VT ablation'], 'description': 'Intracardiac electrode catheters are placed via central vasculature to identify myocardial scar, and surviving conduction channels within the scar which form the substrate for ventricular tachycardia. Radiofrequency energy is applied to these sites, interrupting the VT circuits.', 'armGroupLabels': ['VT catheter ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford General Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Hospital', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': 'T2W 1S7', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Hospital', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V1Y 1T2', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Interior Health Authority', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V6E 1M7', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8R 1J8', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Royal Jubilee Hospital', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'B3H 3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Nova Scotia Health Authority', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8L 8E7', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences Center', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Queen's University Health Sciences Centre", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N2M 1B2', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Mary's Hospital", 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1Y 4W7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Universitaire de Montreal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3H 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Center', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Sacre-Coeur Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut Universitaire de cardiologie et pneumologie de Quebec - Laval University Hosptial', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': '33604', 'city': 'Bordeaux', 'state': 'Acquitaine', 'country': 'France', 'facility': 'Hopitaux de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '54511', 'city': 'Nancy', 'state': 'Meurthe-et-Moselle', 'country': 'France', 'facility': 'CHU - University Hospital Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'John L Sapp, MD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nova Scotia Health Authority'}, {'name': 'Ratika Parkash, MD MSc FRCPC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nova Scotia Health Authoriry'}, {'name': 'Anthony L Tang, MD FRCPC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'London Health Sciences Centre'}, {'name': 'George A Wells, BSc MSc PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ottawa Heart Institute Research Corporation'}, {'name': 'William G Stevenson, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': 'Jeff Healey, MD FRCPC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Population Health Research Institute, McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'John Sapp', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart and Stroke Foundation of Canada', 'class': 'OTHER'}, {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, {'name': 'Biosense Webster, Inc.', 'class': 'INDUSTRY'}, {'name': 'Ottawa Heart Institute Research Corporation', 'class': 'OTHER'}, {'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Cardiac Arrhythmia Network of Canada', 'class': 'OTHER'}, {'name': 'Abbott', 'class': 'INDUSTRY'}, {'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Staff Physician, Division of Cardiology', 'investigatorFullName': 'John Sapp', 'investigatorAffiliation': 'Nova Scotia Health Authority'}}}}