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Completed

NCT Number: NCT00905853

Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

About this study

This is a multicentre, parallel group, two arm, unblinded, randomized clinical trial to compare two management strategies for patients with ischemic heart disease and recurrent ICD therapy despite at least one antiarrhythmic drug. The primary endpoint will be a composite of appropriate ICD shocks or death.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: VT 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

Other names: Cordarone, Mexetil

Primary outcomes

  1. Appropriate ICD shocks,VT storm and death

    Time frame: 3 years

Secondary outcomes

  1. All cause mortality

    Time frame: 3 years

  2. Appropriate ICD antitachycardia pacing anytime and after 1 month treatment period

    Time frame: 3 years

  3. appropriate ICD shocks anytime and after 1 month treatment period

    Time frame: 3 years

  4. Inappropriate shocks anytime and after 1 month treatment period

    Time frame: 3 years

  5. VT storm anytime and after 1 month treatment period

    Time frame: 3 years

  6. Documented sustained VT below detection rate of the ICD any time and after 1 month treatment period

    Time frame: 3 years

  7. Number of ICD shocks

    Time frame: 3 years

  8. Hospital admission for cardiac causes

    Time frame: 3 years

  9. Procedural complications, amiodarone toxicity or adverse events

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

John Sapp

Other

Collaborators

  • Abbott Medical Devices
  • Biosense Webster, Inc.
  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Ventricular Tachycardia Ablation or Escalated aNtiarrhythmic Drugs in ISchemic Heart Disease

Acronym: VANISH

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
May 21, 2009
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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