Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia (CEASE-VT)

Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia: A Multi-center Randomized Trial

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.

Study Overview

• Status: Terminated
• Conditions: Tachycardia, Ventricular; Defibrillators, Implantable
• Intervention / Treatment: Procedure: Ablation; Drug: Amiodarone

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Institut Universitaire de Cardiologie et Pneumologie de Quebec
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton Health Sciences
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Southlake Regional Health Centre
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • McGill University Health Center
• China
  • Beijing, China, 100037
    • Beijng Fuwai Heart Hospital
• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research Foundation
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 84 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ablation; Catheter based radiofrequency ablation for ischemic ventricular tachycardia	Procedure: Ablation; Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization; Other Names: radiofrequency ablation; VT ablation; ischemic VT ablation; catheter ablation
ACTIVE_COMPARATOR: 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.	Drug: 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; Other Names: Cordarone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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
Quality of Life Score	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.	At 6 months follow-up

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Collaborators: Hamilton Health Sciences Corporation; Abbott Medical Devices
• Investigators: Principal Investigator: Andrea Natale, M.D., Texas Cardiac Arrhythmia Research Foundation; Principal Investigator: David J Callans, M.D., University of Pennsylvania; Principal Investigator: Carlos A. Morillo, M.D., Population Health Research Institute, McMaster University; Principal Investigator: Girish M. Nair, M.D., Population Health Research Institute, McMaster University

Publications and helpful links

Helpful Links

• Population Health Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2010
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: March 31, 2010
• First Submitted That Met QC Criteria: March 31, 2010
• First Posted (ESTIMATE): April 1, 2010

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Catheter Ablation; Defibrillators, Implantable; Amiodarone; Tachycardia, Ventricular
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Potassium Channel Blockers; Amiodarone
• Other Study ID Numbers: CEASE-VT