← Back to Search

Antiarrhythmic agents

Ablation vs Drugs for Rapid Heartbeat (VANISH2 Trial)

Phase 4
Waitlist Available
Led By John L Sapp, MD FRCPC
Research Sponsored by John Sapp
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior Myocardial Infarction
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:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 years (including pilot study data)
Awards & highlights

VANISH2 Trial Summary

This trial will compare the two most common treatments for VT to see which is more effective.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Catheter ablation may cause bleeding or infection at the site of insertion, damage to blood vessels or the heart itself. Antiarrhythmic drugs might lead to dizziness, blurred vision, fatigue or worse arrhythmias.

VANISH2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had a heart attack before.
Select...
I had a VT event without taking specific heart rhythm medications in the last 6 months.
Select...
I have had a specific type of irregular heartbeat stopped by medication or a shock treatment.
Select...
I've had 3 or more episodes of fast heartbeats treated, and at least one made me feel symptoms.
Select...
I have had 5 or more episodes of fast heartbeats treated without surgery.
Select...
I have had 3 or more episodes of ventricular tachycardia in a day.

VANISH2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 years (including pilot study data)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 years (including pilot study data) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All-cause mortality
Appropriate ICD shock at least 14 days post randomization
Sustained VT requiring treatment at least 14 days post randomziation
+1 more
Secondary outcome measures
Anti-Arrhythmia Agents
All-cause mortality at any time
Any ICD shock at any time or after 14 days
+21 more

VANISH2 Trial Design

2Treatment groups
Active Control
Group I: Antiarrhythmic Drug TherapyActive Control1 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 ablationActive Control1 Intervention
Catheter ablation of ventricular tachycardia

Find a Location

Who is running the clinical trial?

John SappLead Sponsor
5 Previous Clinical Trials
316 Total Patients Enrolled
Heart and Stroke Foundation of CanadaOTHER
122 Previous Clinical Trials
71,793 Total Patients Enrolled
Abbott Medical DevicesIndustry Sponsor
635 Previous Clinical Trials
404,819 Total Patients Enrolled

Media Library

Ventricular Tachycardia Research Study Groups: Antiarrhythmic Drug Therapy, VT catheter ablation
Ventricular Tachycardia Clinical Trial 2023: Antiarrythmic Drug Therapy Highlights & Side Effects. Trial Name: NCT02830360 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What results is the research team expecting from this trial?

"This medical study, with a total duration of 8 years that includes data from the pilot trial, is aiming to observe ventricular tachycardia storms for at least 14 days post-randomization. As secondary objectives, it will measure any type of ventricular arrhythmia episode after the two week period and evaluate ablation procedural complications or antiarrhythmic drug adverse effects (which may necessitate a subsidiary investigation depending on the complexity of obtained data)."

Answered by AI

Has Antiarrhythmic Drug Therapy been explored in past research endeavors?

"Antiarrhythmic Drug Therapy was first researched in 2011 at Eastbourne General Hospital, with 48 studies already completed. Currently 20 trials are ongoing and the bulk of them take place in London, Ontario."

Answered by AI

How many participants are enrolled in this clinical trial?

"Recruitment for this medical trial concluded on June 20th 2022. As of now, there are 120 active trials with tachycardia and ventricular involvement and 20 different studies exploring Antiarrhythmic Drug Therapy currently recruiting participants."

Answered by AI

Are there presently any open slots for enrollment in this research endeavor?

"This trial has now closed to recruitment, having been originally posted on October 1st 2016 and last updated June 20th 2022. Currently, there are 120 studies seeking participants with tachycardia, ventricular arrhythmia, as well as 20 trials for Antiarrhythmic Drug Therapy requiring patient enrolment."

Answered by AI

To what end is Antiarrhythmic Drug Therapy typically utilized?

"The use of antiarrhythmic drugs is beneficial for cardiothoracic surgical interventions and treating life-threatening ventricular arrhythmias, restoring sinus rhythm, or preventing recurrent ventricular fibrillation."

Answered by AI

How many facilities are executing this clinical trial?

"London Health Sciences Centre in London, Ontario, Queen's University Health Sciences Centre in Kingston, Tennessee and St. Mary's Hospital in Kitchener, British Columbia are some of the many localities where this research is recruiting participants from. An additional 20 sites have been identified as suitable for recruitment."

Answered by AI

Has the FDA authorized Antiarrhythmic Drug Therapy?

"The antiarrhythmic drug therapy was granted a score of 3, owing to its approval following thorough clinical studies in Phase 4."

Answered by AI
~9 spots leftby Jun 2024