Ablation vs Drugs for Rapid Heartbeat

(VANISH2 Trial)

Recruiting in Palo Alto (17 mi)

+24 other locations

Overseen by John L Sapp, MD FRCPC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: John Sapp

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Research Team

John L Sapp, MD FRCPC

Principal Investigator

Nova Scotia Health Authority

Ratika Parkash, MD MSc FRCPC

Principal Investigator

Nova Scotia Health Authoriry

Anthony L Tang, MD FRCPC

Principal Investigator

London Health Sciences Centre

George A Wells, BSc MSc PhD

Principal Investigator

Ottawa Heart Institute Research Corporation

William G Stevenson, MD

Principal Investigator

Brigham and Women's Hospital

Jeff Healey, MD FRCPC

Principal Investigator

Population Health Research Institute, McMaster University

Eligibility Criteria

This trial is for people who've had a heart attack before and now have ventricular tachycardia, which is a fast heartbeat starting in the lower chambers of the heart. They should have experienced at least one shock from an ICD or multiple VT episodes. Pregnant individuals, those unable to consent, with recent heart procedures, severe angina, certain drug allergies or intolerances, kidney failure or advanced heart failure can't participate.

Inclusion Criteria

You have received one or more necessary ICD shocks.

I have had a heart attack before.

I have had 5 or more episodes of fast heartbeats treated without surgery.

Exclusion Criteria

I had a heart attack less than 30 days ago.

I have not had a recent heart attack or severe chest pain, nor have I undergone recent heart surgery.

I cannot take certain heart rhythm medications due to allergies or other reactions.

Treatment Details

Interventions

• Antiarrythmic Drug Therapy (Antiarrhythmic agents)
• Catheter ablation (Procedure)

Trial Overview The study compares two treatments for controlling rapid heartbeat after a previous myocardial infarction: catheter ablation (a procedure that destroys areas of the heart causing irregular beats) versus antiarrhythmic drugs (medications to maintain normal heart rhythm). Participants are randomly assigned to either treatment.

Participant Groups

Group I: Antiarrhythmic Drug Therapy Active Control 1 Intervention

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 II: VT catheter ablation Active Control 1 Intervention

Catheter ablation of ventricular tachycardia

Who Is Running the Clinical Trial?

John Sapp

Lead Sponsor

Trials

6

Recruited

730+

Heart and Stroke Foundation of Canada

Collaborator

Trials

131

Recruited

72,600+

Dr. Stanley Nattel

Heart and Stroke Foundation of Canada

Chief Medical Officer since 2023

MD from University of Toronto

Doug Roth

Heart and Stroke Foundation of Canada

Chief Executive Officer since 2019

MBA from Wilfrid Laurier University

Abbott Medical Devices

Industry Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Biosense Webster, Inc.

Industry Sponsor

Trials

128

Recruited

37,100+

Dr. Nick West

Biosense Webster, Inc.

Chief Medical Officer

MD from Harvard Medical School

Jasmina Brooks

Biosense Webster, Inc.

Chief Executive Officer since 2023

Bachelor of Science in Biomedical Engineering from Louisiana Tech University

Ottawa Heart Institute Research Corporation

Collaborator

Trials

200

Recruited

95,800+

Dr. Thierry Mesana

Ottawa Heart Institute Research Corporation

Chief Medical Officer since 2014

MD from McGill University

Dr. Rob Beanlands

Ottawa Heart Institute Research Corporation

Chief Executive Officer since 2024

MD from the University of Ottawa

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa

Cardiac Arrhythmia Network of Canada

Collaborator

Trials

14

Recruited

8,400+

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Nova Scotia Health Authority

Collaborator

Trials

302

Recruited

95,300+

Karen Oldfield

Nova Scotia Health Authority

Chief Executive Officer since 2021

Past Chair of the Board of Governors of Saint Mary’s University

Dr. Robert Strang

Nova Scotia Health Authority

Chief Medical Officer

MD