Clinical trial NCT01097330: Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia
Official title: Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia: A Multi-center Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Defibrillators, Implantable
Tachycardia, Ventricular
Keywords: Defibrillators, Implantable
Tachycardia, Ventricular
Catheter Ablation
Amiodarone
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
name: Hamilton Health Sciences Corporation
First posted: 2010-04-01
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria - Patients must meet all of the following criteria:

* \> 18 and \< 85 years of age
* ICD implanted for primary prophylaxis against sudden cardiac death or ICD implanted for secondary prophylaxis against spontaneous or inducible sustained VT without any reversible causes
* Coronary artery disease (CAD) with prior myocardial infarction (MI)
* ICD or electrocardiogram (ECG) documentation of ventricular arrhythmia responsible for appropriate ICD therapy \[antitachycardia pacing (ATP) \& shocks\].

Exclusion Criteria - Patients should not have any of the following criteria:

* Contraindication or allergy to contrast media, routine procedural medications or catheter materials
* Contraindication to an interventional procedure
* Current or previous (within 3 months) amiodarone therapy
* Atrial Fibrillation requiring antiarrhythmic drug therapy
* Contraindication to amiodarone therapy
* New York Heart Association (NYHA) functional class IV
* Myocardial infarction within the past 60 days
* 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
* Patients 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. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable.
* Current enrollment in another investigational drug or device study.
* Presence of any other condition that the investigator feels would be problematic or would restrict or limit the participation of the patient for the entire study period.
* Absolute contra-indication to the use of heparin and or warfarin.
* Documented intra-atrial thrombus, ventricular thrombus (\< 6 months after detection of thrombus), tumor, or another abnormality which precludes catheter introduction.
* Females of childbearing potential who are not practicing protocol acceptable method of birth control.

Primary outcomes:
measure: Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death
timeFrame: From 30 days following randomization until final follow-up visit
Secondary outcomes:
measure: 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.
timeFrame: from randomization until final follow-up
measure: Quality of Life Score
timeFrame: At 6 months follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et Pneumologie de Québec
city: Beijing
country: China
facility: Beijng Fuwai Heart Hospital
Study officials:
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Andrea Natale, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: David J Callans, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute, McMaster University
name: Carlos A. Morillo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute, McMaster University
name: Girish M. Nair, M.D.
role: PRINCIPAL_INVESTIGATOR
References: