Anti-arrhythmic Therapy vs Catheter Ablation as First Line Treatment for AICD Shock Prevention (NCT02114528) | Clinical Trial Compass
TerminatedPhase 4
Anti-arrhythmic Therapy vs Catheter Ablation as First Line Treatment for AICD Shock Prevention
Stopped: Low recruitment. Pilot trial.
Canada3 participantsStarted 2014-10
Plain-language summary
The purpose of this study is to determine whether catheter based ablation is better than conventional anti-arrhythmic drug (AAD) therapy for reducing recurrent shocks in patients with an implantable cardioverter defibrillator (ICD). The second purpose of the study is to determine the safety of catheter-based ablation and the effect on quality of life of patients.
The study hypothesis is that catheter ablation is superior to AAD therapy in preventing recurrent ventricular arrhythmia in such subjects. This is a pilot trial which will provide data regarding recruitment potential and the feasibility of conducting a larger trial.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥ 18 and ≤ 85 years old
* Able to provide informed consent
* AICD implanted for primary prophylaxis against sudden cardiac death
* AICD implanted for secondary prophylaxis against spontaneous or inducible sustained VT without any reversible causes
* CAD with prior myocardial infarction (\>60 days prior to enrollment)
* AICD or ECG documentation of ventricular arrhythmia responsible for appropriate AICD therapy (\> 3 ATP or ≥ 1 appropriate Shock)
Exclusion Criteria:
* Contraindication or allergy to contrast media, routine procedural medications or catheter materials
* Contraindication to an interventional procedure
* Current or previous (within 3 months) antiarrhythmic therapy
* Absolute contraindication to amiodarone or other AAD
* New York Heart Association (NYHA) functional class IV
* Stroke within the past 90 days
* Unstable angina
* Hypertrophic cardiomyopathy, Non-ischemic dilated cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Brugada Syndrome, Catecholamine sensitive polymorphic VT or long QT syndrome
* Subjects with active ischemia that are eligible for revascularization
* Life expectancy less than 6 months
* Incessant or multiple episodes of VT requiring immediate therapy with medications or ablation
* Untreated hypothyroidism or hyperthyroidism. Subjects who are euthyroid on thyroid hormone replacement therapy are acceptable.
* Current enrollment in another investigational drug or device study.
* Presence of any other condition t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Appropriate ICD therapy
Timeframe: After 30 day treatment period
Trial details
NCT IDNCT02114528
SponsorOttawa Heart Institute Research Corporation