Anti-arrhythmic Therapy vs Catheter Ablation as First Line Treatment for AICD Shock Prevention (AVATAR)
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|ClinicalTrials.gov Identifier: NCT02114528|
Recruitment Status : Terminated (Low recruitment. Pilot trial.)
First Posted : April 15, 2014
Last Update Posted : November 17, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Tachycardia Ventricular Arrhythmia||Drug: Antiarrhythmic Drug Therapy Procedure: Catheter ablation||Phase 4|
AAD and catheter ablation have been shown to reduce the incidence of recurrent AICD shocks. The disadvantages of AAD include side effects from medications and the lack of compliance during long-term therapy. Previous trials have demonstrated the feasibility, safety and efficacy of catheter ablation as "first-line" treatment for reducing recurrent ventricular arrhythmia and AICD shocks in this subject population. However, these catheter ablation trials did not systematically compare the efficacy of catheter ablation with AAD therapy. While both treatment strategies have been shown to be effective in this setting it is unclear how they compare with each other in preventing AICD shocks.
This is a single centre, parallel group, two-arm, unblinded randomized vanguard pilot trial comparing catheter ablation with AAD therapy for preventing recurrent AICD shocks.
Eligible and consenting subjects will be equally randomized to receive either AAD therapy or a catheter ablation procedure.
A 30-day treatment period will be provided to allow for adequate time to implement the two treatments.
Subjects randomized to the antiarrhythmic therapy arm will receive clinically effective loading doses of either sotalol, mexiletine, procainamide or amiodarone (oral or IV) alone or in combination, as chosen by the study investigator.
Subjects randomized to the catheter ablation arm will undergo the procedure within the 30 treatment period. Concomitant antiarrhythmic therapy with amiodarone or other AAD will be avoided if possible in the ablation group. However, AAD may be used to suppress ventricular arrhythmia resulting in AICD shocks or anti-tachycardia pacing (ATP) while waiting for the catheter ablation procedure.
Subjects will be seen for a baseline randomization visit, then at 3, 6, 9 and 12 months after enrollment and every 3 months thereafter until the end of the study. Subjects will be followed up for a minimum of 12 months and a maximum of 24 months.
Quality of life questionnaires will be done at each visit. Standard of care blood work, chest x-ray, and ECG will be done in the AAD arm depending on the AAD chosen as treatment. ICD programming will be standardized for all subjects.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Antiarrhythmic Therapy Versus Catheter Ablation as First Line Treatment for AICD Shock Prevention: A Randomized Vanguard Pilot Trial|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Active Comparator: Anti-arrhythmic drug therapy
Oral and/or intravenous loading doses of Sotalol, mexiletine, procainamide or amiodarone as first line therapy. Drug chosen is preference of the treating physician. May use single or combination of AAD. Loading doses as per standard dosing guidelines for VT. Subjects on amiodarone should receive oral maintenance dose of at least 200 mg/day.
Drug: Antiarrhythmic Drug Therapy
Either one or more of the following antiarrhythmic drugs: sotalol, mexiletine, procainamide, or amiodarone.
Other Name: Betapace (sotalol), Mexitil (mexiletine), Pronestyl (procainamide), Cordarone (amiodarone)
Active Comparator: Catheter ablation
Ventricular tachycardia (VT) Catheter ablation, using a standardized VT ablation procedure protocol.
Procedure: Catheter ablation
Ventricular tachycardia catheter ablation.
- Appropriate ICD therapy [ Time Frame: After 30 day treatment period ]Appropriate AICD therapy after the 30 day treatment period; defined as ≥ 1 appropriate Shock or ATP that needs further intervention in the form of catheter ablation or AAD therapy.
- Composite Safety Endpoint [ Time Frame: Up to 24 months ]
- Catheter ablation arm- procedure related complications, need for concomitant use of AAD (sotalol, mexiletine, propafenone or amiodarone) and/or death.
- Antiarrhythmic arm- medication side effects, discontinuation of AAD and death, inappropriate shocks from AICD.
- Slow VT below AICD tachyarrhythmia detection threshold that leads to hospitalization or necessitates catheter ablation
- Quality of life score in each treatment arm using the EQ-5D questionnaire
- Health care resource utilization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114528
|University of Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Principal Investigator:||Girish Nair, MD||Ottawa Heart Institute Research Corporation|