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
  Purpose
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.

Condition Intervention Phase
Recurrent Ventricular Tachycardia
Procedure: Catheter Ablation
Drug: Escalated Antiarrhythmic Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ventricular Tachycardia Ablation or Escalated aNtiarrhythmic Drugs in ISchemic Heart Disease

Resource links provided by NLM:


Further study details as provided by Nova Scotia Health Authority:

Primary Outcome Measures:
  • Appropriate ICD shocks,VT storm and death [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 260
Study Start Date: May 2009
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ventricular Tachycardia Ablation
Catheter ablation for Ventricular tachycardia will be performed within 14 days of randomization.
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
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.
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

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905853

Locations
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
John Sapp
St. Jude Medical
Biosense Webster, Inc.
Canadian Institutes of Health Research (CIHR)
Investigators
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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Sapp, Staff physician, Division of Cardiology, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT00905853     History of Changes
Other Study ID Numbers: Sapp001 
Study First Received: May 20, 2009
Last Updated: July 8, 2016
Health Authority: Canada: Health Canada
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Nova Scotia Health Authority:
Ventricular Tachycardia
Catheter Ablation
ICD therapy
Antiarrhythmic Drug Therapy
Ischemic Heart Disease

Additional relevant MeSH terms:
Tachycardia
Myocardial Ischemia
Coronary Artery Disease
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Amiodarone
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors

ClinicalTrials.gov processed this record on July 28, 2016