Anti-arrhythmic Therapy vs Catheter Ablation as First Line Treatment for AICD Shock Prevention

NCT02114528 | Terminated Phase 4 DMC

• 1 other identifier: 20130425
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventricular Tachycardia; Ventricular Arrhythmia

Keywords

Ventricular Tachycardia; Ventricular Arrhythmia; Anti-arrhythmic drugs; Catheter Ablation; ICD Shocks

Outcome Measures

Primary Outcomes (1)

• Appropriate ICD therapy

  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.

  After 30 day treatment period

Secondary Outcomes (1)

• Composite Safety Endpoint

  Up to 24 months

Study Arms (2)

Anti-arrhythmic drug therapy

ACTIVE COMPARATOR

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

Catheter ablation

ACTIVE COMPARATOR

Ventricular tachycardia (VT) Catheter ablation, using a standardized VT ablation procedure protocol.

Procedure: Catheter ablation

Interventions

Antiarrhythmic Drug Therapy DRUG

Either one or more of the following antiarrhythmic drugs: sotalol, mexiletine, procainamide, or amiodarone.

Also known as: Betapace (sotalol), Mexitil (mexiletine), Pronestyl (procainamide), Cordarone (amiodarone)

Anti-arrhythmic drug therapy

Catheter ablation PROCEDURE

Ventricular tachycardia catheter ablation.

Catheter ablation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 and ≤ 85 years old
• Able to provide informed consent
• AICD implanted for primary prophylaxis against sudden cardiac death
• AICD implanted for secondary prophylaxis against spontaneous or inducible sustained VT without any reversible causes
• CAD with prior myocardial infarction (\>60 days prior to enrollment)
• AICD or ECG documentation of ventricular arrhythmia responsible for appropriate AICD therapy (\> 3 ATP or ≥ 1 appropriate Shock)

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) antiarrhythmic therapy
• Absolute contraindication to amiodarone or other AAD
• New York Heart Association (NYHA) functional class IV
• 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
• Subjects 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. Subjects 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 Subject for the entire study period.
• Absolute contra-indication to the use of heparin and or warfarin.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Sotalol; Mexiletine; Procainamide; Amiodarone; Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Propylamines; Phenyl Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Girish Nair, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 15, 2014
• Study Start: October 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 4, 2026

Record last verified: 2015-11

Locations

CA (1)