Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy

NCT00905853 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2016-07-11

No results posted yet for this study

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

Interventions

PROCEDURE

Catheter Ablation

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.

DRUG

Escalated Antiarrhythmic Therapy

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

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY
  • Biosense Webster, Inc.

    collaborator INDUSTRY
  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • John Sapp

    lead OTHER

Principal Investigators

  • John L Sapp, BSc, MD, FRCPC · Nova Scotia Health Authority

  • Ratika Parkash, MD, MSc, FRCPC · Nova Scotia Health Authority

  • Anthony S Tang, MSc, MD, FRCPC · Royal Jubilee Hospital

  • George A Wells, BSc,MSc,PhD · Univeristy of Ottawa Heart Institute

  • William G Stevenson, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00905853 on ClinicalTrials.gov