Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy

NCT00905853 | Completed Phase 4 DMC

• 1 other identifier: Sapp001
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare aggressive antiarrhythmic therapy to catheter ablation for ventricular tachycardia in patients who have suffered prior myocardial infarction. The purpose of this study is to evaluate the optimal management of patients presenting with recurrent VT and receiving ICD therapy in spite of first-line antiarrhythmic drug therapy. The hypothesis is catheter ablation is superior to aggressive antiarrhythmic drug therapy for recurrent VT.

Conditions

Recurrent Ventricular Tachycardia

Keywords

Ventricular Tachycardia; Catheter Ablation; ICD therapy; Antiarrhythmic Drug Therapy; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Appropriate ICD shocks,VT storm and death

  3 years

Secondary Outcomes (9)

• All cause mortality

  3 years

• Appropriate ICD antitachycardia pacing anytime and after 1 month treatment period

  3 years

• appropriate ICD shocks anytime and after 1 month treatment period

  3 years

• Inappropriate shocks anytime and after 1 month treatment period

  3 years

• VT storm anytime and after 1 month treatment period

  3 years

Study Arms (2)

Ventricular Tachycardia Ablation

ACTIVE COMPARATOR

Catheter ablation for Ventricular tachycardia will be performed within 14 days of randomization.

Procedure: Catheter Ablation

Escalated Antiarrhythmic Drug Therapy

ACTIVE COMPARATOR

Patients are prescribed a loading dose of amiodarone or the addition of mexiletine to their current anti-arrhythmic medication which is stratified by the dose and type of antiarrhymic medication at the time of the index arrhythmic event.

Drug: Escalated Antiarrhythmic Therapy

Interventions

Catheter Ablation PROCEDURE

Intracardiac electrode catheters are placed via central vasculature to identify myocardial scar, and surviving conduction channels within the scar which form the substrate for ventricular tachycardia. Radiofrequency energy is applied to these sites, interrupting the VT circuits.

Also known as: VT Ablation

Ventricular Tachycardia Ablation

Escalated Antiarrhythmic Therapy DRUG

Patients who have 'failed' antiarrhythmic therapy (except amiodarone) will be prescribed: Amiodarone 400 mg twice daily for 2 weeks, followed by 400 mg/day for 4 weeks, followed by 200 mg/day thereafter. Patients who 'failed' amiodarone (less than 300mg/day) will be prescribed: Amiodarone 400 mg three times a day for 2 weeks, followed by 400 mg/day for 1 week and 300 mg/day thereafter. Patients who 'failed' amiodarone (greater or equal to 300mg/day) will be prescribed: Amiodarone at the current dose with the addition of mexiletine 400 to 800 mg/day

Also known as: Cordarone, Mexetil

Escalated Antiarrhythmic Drug Therapy

Eligibility Criteria

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

You may qualify if:

• Prior Myocardial Infarction
• An implantable defibrillator
• One of the following VT events (within the past 3 months):
• greater than or equal to 3 episodes of symptomatic VT treated with ATP
• greater than or equal to 1 appropriate ICD shock
• greater than or equal to 3 VT episodes within 24 hours
• sustained VT below detection rate of the ICD documented by ECG
• "Failed" first-line antiarrhythmic drug therapy as defined by one of:
• Appropriate ICD therapy or sustained VT occurred while patient was taking amiodarone (stable dose \>/= 2 weeks)
• Appropriate ICD therapy or sustained VT occurred on another antiarrhythmic drug (stable dose \>/= 2 weeks)

You may not qualify if:

• Active ischemia (acute thrombus, dynamic ST elevation on ECG) or another reversible cause of VT (eg. electrolyte abnormalities, drug induced arrhythmia)
• Are known to be ineligible to take amiodarone (eg. active hepatitis, current hyperthyroidism, pulmonary fibrosis, known allergy)
• Are ineligible for ablation (left ventricular thrombus, implanted mechanical aortic and mitral valves)
• Renal Failure (creatinine clearance \< 15 ml/min)
• Current NYHA functional class IV heart failure or CCS Functional Class IV angina
• Recent ST elevation myocardial infarction (\< 1 month)
• Recent coronary bypass surgery (\< 3 mon) or recent PCI (\< 1 mon)
• Pregnant
• prior ablation for ventricular tachycardia
• A systemic illness likely to limit survival to \< 1 year
• Unable or unwilling to provide informed consent

Sponsors & Collaborators

• John Sapp: lead
• Abbott Medical Devices: collaborator
• Biosense Webster, Inc.: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Related Publications (2)

• Parkash R, Nault I, Rivard L, Gula L, Essebag V, Nery P, Tung S, Raymond JM, Sterns L, Doucette S, Wells G, Tang ASL, Stevenson WG, Sapp JL. Effect of Baseline Antiarrhythmic Drug on Outcomes With Ablation in Ischemic Ventricular Tachycardia: A VANISH Substudy (Ventricular Tachycardia Ablation Versus Escalated Antiarrhythmic Drug Therapy in Ischemic Heart Disease). Circ Arrhythm Electrophysiol. 2018 Jan;11(1):e005663. doi: 10.1161/CIRCEP.117.005663.

  PMID: 29305400 DERIVED

• Sapp JL, Wells GA, Parkash R, Stevenson WG, Blier L, Sarrazin JF, Thibault B, Rivard L, Gula L, Leong-Sit P, Essebag V, Nery PB, Tung SK, Raymond JM, Sterns LD, Veenhuyzen GD, Healey JS, Redfearn D, Roux JF, Tang AS. Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs. N Engl J Med. 2016 Jul 14;375(2):111-21. doi: 10.1056/NEJMoa1513614. Epub 2016 May 5.

  PMID: 27149033 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular; Myocardial Ischemia

Interventions

Catheter Ablation; Amiodarone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• John L Sapp, BSc, MD, FRCPC

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

• Ratika Parkash, MD, MSc, FRCPC

  Nova Scotia Health Authority

  STUDY DIRECTOR

• Anthony S Tang, MSc, MD, FRCPC

  Royal Jubilee Hospital

  STUDY DIRECTOR

• George A Wells, BSc,MSc,PhD

  Univeristy of Ottawa Heart Institute

  STUDY DIRECTOR

• William G Stevenson, MD

  Brigham and Women's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff physician, Division of Cardiology

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 21, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 11, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)