Ventricular Tachycardia (VT) Ablation Versus Enhanced Drug Therapy (VANISH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Capital District Health Authority, Canada
Sponsor:
Collaborators:
St. Jude Medical
Biosense Webster, Inc.
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
John Sapp, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00905853
First received: May 20, 2009
Last updated: March 31, 2014
Last verified: March 2014

May 20, 2009
March 31, 2014
May 2009
January 2015   (final data collection date for primary outcome measure)
Appropriate ICD shocks,VT storm and death [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Appropriate ICD shocks and death [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00905853 on ClinicalTrials.gov Archive Site
All cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ventricular Tachycardia (VT) Ablation Versus Enhanced Drug Therapy
Ventricular Tachycardia Ablation vs. Enhanced Drug Therapy in Structural Heart Disease

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with ischemic heart disease presenting with appropriate ICD therapy for ventricular tachycardia in spite of first-line antiarrhythmic drug therapy.

Recurrent Ventricular Tachycardia
  • 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.
    Other Name: VT Ablation
  • Drug: Aggressive Antiarrhythmic Therapy (Amiodarone)

    Patients who have 'failed' antiarrhythmic therapy (except amiodarone) -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) - 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) - Amiodarone at the current dose with the addition of mexiletine 400-800 mg/day

    Other Names:
    • Cordarone
    • Mexetil
Ischemic Heart Disease, Recurrent VT, ICD
Patients with prior myocardial infarction who have experienced recurrent appropriate ICD therapy for ventricular tachycardia in spite of first-line antiarrhythmic drug therapy.
Interventions:
  • Procedure: Catheter Ablation
  • Drug: Aggressive Antiarrhythmic Therapy (Amiodarone)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
260
January 2018
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: John L Sapp, BSc., M.D., FRCP(C) 902-473-4272 sappj@cdha.nshealth.ca
Contact: Ratika Parkash, MD, MSc, FRCP(C) 902-473-4474 ratika.parkash@cdha.nshealth.ca
Canada
 
NCT00905853
Sapp001
Yes
John Sapp, Capital District Health Authority, Canada
John Sapp
  • St. Jude Medical
  • Biosense Webster, Inc.
  • Canadian Institutes of Health Research (CIHR)
Principal Investigator: John L Sapp, BSc, MD, FRCPC Capital District Health Authority, Canada
Study Director: Ratika Parkash, MD, MSc, FRCPC Capital District Health Authority, Canada
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
Capital District Health Authority, Canada
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP