Antiarrhythmics or Ablation for Ventricular Tachycardia 2

NCT02830360 | Completed Phase 4 DMC

• 1 other identifier: SAPP004
• Study Type: interventional
• Target: 416
• Locations: 3 countries
• Sites: 22

Brief Summary

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).

Conditions

Ventricular Tachycardia (VT)

Keywords

Antiarrhythmic drug therapy; VT Catheter ablation; ICD Therapy; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (4)

• All-cause mortality

  Time to any death occurring at any time post randomization

  8 years (including pilot study data)

• Appropriate ICD shock at least 14 days post randomization

  Time to first appropriate ICD shock after 14 days post randomization

  8 years (including pilot study data)

• VT storm at least 14 days post randomization

  Time to 3 or more episodes of VT within 24 hours

  8 years (including pilot study data)

• Sustained VT requiring treatment at least 14 days post randomziation

  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

  8 years (including pilot study data)

Secondary Outcomes (25)

• All-cause mortality at any time

  8 years (including pilot study data)

• Appropriate ICD ATP at any time or after 14 days

  8 years (including pilot study data)

• Appropriate shocks at any time or after 14 days

  8 years (including pilot study data)

• VT storm at any time or after 14 days

  8 years (including pilot study data)

• Sustained VT not treated by ICD at any time or after 14 days

  8 years (including pilot study data)

Study Arms (2)

VT catheter ablation

ACTIVE COMPARATOR

Catheter ablation of ventricular tachycardia

Procedure: Catheter ablation

Antiarrhythmic Drug Therapy

ACTIVE COMPARATOR

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).

Drug: Antiarrythmic Drug Therapy

Interventions

Antiarrythmic Drug Therapy DRUG

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.)

Also known as: Amiodarone (Cordarone) or Sotalol (Sotacor)

Antiarrhythmic Drug Therapy

Catheter ablation PROCEDURE

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.

Also known as: VT ablation

VT catheter ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior Myocardial Infarction and
• 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:
• Sustained monomorphic VT documented on 12-lead ECG or rhythm strip terminated by pharmacologic means or DC cardioversion
• ≥3 episodes of VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic
• ≥ 5 episodes of VT treated with antitachycardia pacing (ATP) regardless of symptoms
• ≥1 appropriate ICD shocks,
• ≥3 VT episodes within 24 hours

You may not qualify if:

• Unable or unwilling to provide informed consent.
• 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.
• Are ineligible to take the antiarrhythmic drug to which they would be assigned due to allergy, intolerance or contraindication
• Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves
• Have had a prior catheter ablation procedure for VT
• Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF)
• 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
• 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.
• Are pregnant.

Sponsors & Collaborators

• John Sapp: lead
• Heart and Stroke Foundation of Canada: collaborator
• Abbott Medical Devices: collaborator
• Biosense Webster, Inc.: collaborator
• Ottawa Heart Institute Research Corporation: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Cardiac Arrhythmia Network of Canada: collaborator
• Abbott: collaborator
• Nova Scotia Health Authority: collaborator

Study Sites (22)

Hartford General Hospital

Hartford, Connecticut, 06102, United States

Location

Vanderbilt University Hospital

Nashville, Tennessee, 37232, United States

Location

Foothills Hospital

Calgary, Alberta, T2W 1S7, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Interior Health Authority

Kelowna, British Columbia, V1Y 1T2, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6E 1M7, Canada

Location

Royal Jubilee Hospital

Victoria, British Columbia, V8R 1J8, Canada

Location

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Hamilton Health Sciences Center

Hamilton, Ontario, L8L 8E7, Canada

Location

Queen's University Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

St. Mary's Hospital

Kitchener, Ontario, N2M 1B2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Centre Hospitalier de l'Universitaire de Montreal

Montreal, Quebec, H2X 0A9, Canada

Location

McGill University Health Center

Montreal, Quebec, H3H 1A4, Canada

Location

Sacre-Coeur Hospital

Montreal, Quebec, H4J 1C5, Canada

Location

Institut Universitaire de cardiologie et pneumologie de Quebec - Laval University Hosptial

Québec, Quebec, G1V 4G5, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Hopitaux de Bordeaux

Bordeaux, Acquitaine, 33604, France

Location

CHU - University Hospital Nancy

Nancy, Meurthe-et-Moselle, 54511, France

Location

Related Publications (4)

• 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. 2026 Jan 20;87(2):157-168. doi: 10.1016/j.jacc.2025.09.1595. Epub 2025 Oct 11.

  PMID: 41217320 DERIVED

• 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: 39555820 DERIVED

• 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: 38649085 DERIVED

• 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.

  PMID: 31698933 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular; Myocardial Ischemia

Interventions

Amiodarone; Sotalol; Catheter Ablation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• John L Sapp, MD FRCPC

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

• Ratika Parkash, MD MSc FRCPC

  Nova Scotia Health Authoriry

  STUDY DIRECTOR

• Anthony L Tang, MD FRCPC

  London Health Sciences Centre

  STUDY DIRECTOR

• George A Wells, BSc MSc PhD

  Ottawa Heart Institute Research Corporation

  STUDY DIRECTOR

• William G Stevenson, MD

  Brigham and Women's Hospital

  STUDY DIRECTOR

• Jeff Healey, MD FRCPC

  Population Health Research Institute, McMaster University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician, Division of Cardiology

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: July 12, 2016
• Study Start: October 1, 2016
• Primary Completion: June 6, 2024
• Study Completion: June 30, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); US (2); CA (18)