Antiarrhythmics or Ablation for Ventricular Tachycardia 2

NCT ID: NCT02830360

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 416 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2024-06-30

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).

Detailed Description

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.

The 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.

Conditions

Ventricular Tachycardia (VT)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VT catheter ablation

Catheter ablation of ventricular tachycardia

Group Type: ACTIVE_COMPARATOR

Catheter ablation

Intervention Type: 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.

Antiarrhythmic Drug Therapy

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).

Group Type: ACTIVE_COMPARATOR

Antiarrythmic Drug Therapy

Intervention Type: 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.)

Interventions

Antiarrythmic Drug Therapy

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.)

Intervention Type: DRUG

Catheter ablation

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.

Intervention Type: PROCEDURE

Other Intervention Names

Amiodarone (Cordarone) or Sotalol (Sotacor); VT ablation

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Stroke Foundation of Canada

OTHER

Sponsor Role: collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: collaborator

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Cardiac Arrhythmia Network of Canada

OTHER

Sponsor Role: collaborator

Abbott

INDUSTRY

Sponsor Role: collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role: collaborator

John Sapp

OTHER

Sponsor Role: lead

Responsible Party

John Sapp

Staff Physician, Division of Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John L Sapp, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Ratika Parkash, MD MSc FRCPC

Role: STUDY_DIRECTOR

Nova Scotia Health Authoriry

Anthony L Tang, MD FRCPC

Role: STUDY_DIRECTOR

London Health Sciences Centre

George A Wells, BSc MSc PhD

Role: STUDY_DIRECTOR

Ottawa Heart Institute Research Corporation

William G Stevenson, MD

Role: STUDY_DIRECTOR

Brigham and Women's Hospital

Jeff Healey, MD FRCPC

Role: STUDY_DIRECTOR

Population Health Research Institute, McMaster University

Locations

Hartford General Hospital

Hartford, Connecticut, United States

Vanderbilt University Hospital

Nashville, Tennessee, United States

Foothills Hospital

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

Interior Health Authority

Kelowna, British Columbia, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

Royal Jubilee Hospital

Victoria, British Columbia, Canada

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Hamilton Health Sciences Center

Hamilton, Ontario, Canada

Queen's University Health Sciences Centre

Kingston, Ontario, Canada

St. Mary's Hospital

Kitchener, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Centre Hospitalier de l'Universitaire de Montreal

Montreal, Quebec, Canada

McGill University Health Center

Montreal, Quebec, Canada

Sacre-Coeur Hospital

Montreal, Quebec, Canada

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

Québec, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Hopitaux de Bordeaux

Bordeaux, Acquitaine, France

CHU - University Hospital Nancy

Nancy, Meurthe-et-Moselle, France

Countries

United States; Canada; France

References

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.

Reference Type: DERIVED

PMID: 39555820 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38649085 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31698933 (View on PubMed)

Other Identifiers

SAPP004

Identifier Type: -

Identifier Source: org_study_id