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

NCT01097330 | Terminated Phase 3 Results

• 1 other identifier: CEASE-VT
• Study Type: interventional
• Target: 12
• Locations: 3 countries
• Sites: 11

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.

Conditions

Defibrillators, Implantable; Tachycardia, Ventricular

Keywords

Defibrillators, Implantable; Tachycardia, Ventricular; Catheter Ablation; Amiodarone

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death

  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

  From 30 days following randomization until final follow-up visit

Secondary Outcomes (2)

• 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

  At 6 months follow-up

Study Arms (2)

Ablation

ACTIVE COMPARATOR

Catheter based radiofrequency ablation for ischemic ventricular tachycardia

Procedure: Ablation

Amiodarone

ACTIVE COMPARATOR

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

Interventions

Ablation PROCEDURE

Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization

Also known as: VT ablation, ischemic VT ablation, catheter ablation, radiofrequency ablation

Ablation

Amiodarone DRUG

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

Also known as: Cordarone

Amiodarone

Eligibility Criteria

• Age: 19 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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 \[antitachycardia pacing (ATP) \& shocks\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• Population Health Research Institute: lead
• Abbott Medical Devices: collaborator
• Hamilton Health Sciences Corporation: collaborator

Study Sites (11)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

McGill University Health Center

Montreal, Quebec, H3G 1A4, Canada

Location

Institut Universitaire de Cardiologie et Pneumologie de Québec

Québec, G1V 4G5, Canada

Location

Beijng Fuwai Heart Hospital

Beijing, 100037, China

Location

Related Links

• Population Health Research Institute

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Catheter Ablation; Radiofrequency Ablation; Amiodarone

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Carlos Morillo
• Organization: Population Health Research Institute

Carlos.Morillo@phri.ca

905-527-4322

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 1, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: January 29, 2020
• Results First Posted: January 29, 2020

Record last verified: 2020-01

Locations

CN (1); US (5); CA (5)