Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia

Phase 3

Terminated

• Conditions: Tachycardia, Ventricular; Defibrillators, Implantable
• Interventions: Procedure: Ablation; Drug: Amiodarone

• Registration Number: NCT01097330
• Lead Sponsor: Population Health Research Institute

Brief Summary

Implantable Cardioverter Defibrillators (ICDs) provide a shock or pacing therapy to bring back a normal heart beat when a patient experiences a dangerous abnormal heart rhythm such as ventricular tachycardia (VT). ICDs are very successful in bringing back a normal heart beat when VT occurs, but they do not prevent further dangerous heart rhythms from occurring. This study is designed to determine the best way to manage patients who have an ICD and who continue to have episodes of VT. There are two methods for treatment the VT: 1) Ablation, and 2) Medication.

An ablation procedure involves placing a flexible catheter (insulated wire) in the groin area and threading it into the heart. After the doctor has located the affected area responsible for the VT, radiofrequency energy is delivered by the power generator through the catheter to the inside of the heart. The radiofrequency energy ablates (burns) a small area of the heart tissue thought to cause the VT.

A medication called Amiodarone is an "anti-arrhythmic" prescribed to prevent abnormal heart rhythms from recurring.

The purpose of this study is to compare these two different methods for treating VT. Treatment with ablation and amiodarone are both considered the standard of care for patients with VT but they have not been compared directly in a study like this before.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-31
• Study First Submitted QC: 2010-03-31
• Study First Posted: 2010-04-01
• Study Start: 2010-08
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2015-12-30
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-17
• Last Update Submitted: 2020-01-17
• Results First Posted: 2020-01-29
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ablation	Ablation	Catheter based radiofrequency ablation for ischemic ventricular tachycardia
Amiodarone	Amiodarone	amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death	From 30 days following randomization until final follow-up visit	Number of participants with a composite outcome of any of: 1. Appropriate Implantable Cardioverter Defibrillator (ICD) therapy \[Including antitachycardia pacing (ATP) and shocks\]; 2. Slow ventricular tachycardia (VT) below ICD detection threshold leading to hospitalization or necessitates antiarrhythmic medications and/or catheter ablation; 3. Sudden Cardiac Death

Secondary Outcome Measures

Name	Time	Method
Number of Participants With (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks From ICD, or (c) Need for Concomitant Use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic Agents in Either Arm of the Trial.	from randomization until final follow-up	Number of Participants with (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks from ICD, or (c) Need for Concomitant use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic agents in either arm of the trial.
Quality of Life Score	At 6 months follow-up	Quality of life score in each treatment arm using the EQ-5D Visual Analogue Scale (VAS) (euroqol.org). The EQ-5D VAS is a patient reported scale from 0 to 100 on which the patient rates how good or bad their health is today with 100 being the best health they can imagine and 0 being the worst health they can imagine.

Trial Locations

Locations (11)

Texas Cardiac Arrhythmia Research Foundation; 🇺🇸 Austin, Texas, United States

Southlake Regional Health Centre; 🇨🇦 Newmarket, Ontario, Canada

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

McGill University Health Center; 🇨🇦 Montreal, Quebec, Canada

Beijng Fuwai Heart Hospital; 🇨🇳 Beijing, China

Institut Universitaire de Cardiologie et Pneumologie de Québec; 🇨🇦 Quebec, Canada