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Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy (VANISH)

This study has been completed.
Sponsor:
Collaborators:
St. Jude Medical
Biosense Webster, Inc.
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
John Sapp, Nova Scotia Health Authority
ClinicalTrials.gov Identifier:
NCT00905853
First received: May 20, 2009
Last updated: July 8, 2016
Last verified: July 2016

May 20, 2009
July 8, 2016
May 2009
December 2015   (final data collection date for primary outcome measure)
Appropriate ICD shocks,VT storm and death [ Time Frame: 3 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: 3 years ] [ Designated as safety issue: No ]
  • Appropriate ICD antitachycardia pacing anytime and after 1 month treatment period [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • appropriate ICD shocks anytime and after 1 month treatment period [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Inappropriate shocks anytime and after 1 month treatment period [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • VT storm anytime and after 1 month treatment period [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Documented sustained VT below detection rate of the ICD any time and after 1 month treatment period [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Number of ICD shocks [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Hospital admission for cardiac causes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Procedural complications, amiodarone toxicity or adverse events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
All cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy
Ventricular Tachycardia Ablation or Escalated aNtiarrhythmic Drugs in ISchemic 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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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: 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

    Other Names:
    • Cordarone
    • Mexetil
  • Active Comparator: Ventricular Tachycardia Ablation
    Catheter ablation for Ventricular tachycardia will be performed within 14 days of randomization.
    Intervention: Procedure: Catheter Ablation
  • Active Comparator: Escalated Antiarrhythmic Drug Therapy
    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.
    Intervention: Drug: Escalated Antiarrhythmic Therapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
260
December 2015
December 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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00905853
Sapp001
Yes
No
Not Provided
John Sapp, Nova Scotia Health Authority
John Sapp
  • St. Jude Medical
  • Biosense Webster, Inc.
  • Canadian Institutes of Health Research (CIHR)
Principal Investigator: John L Sapp, BSc, MD, FRCPC Nova Scotia Health Authority
Study Director: 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
Nova Scotia Health Authority
July 2016

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