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
  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
Recurrent Ventricular Tachycardia
Procedure: Catheter Ablation
Drug: Aggressive Antiarrhythmic Therapy (Amiodarone)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ventricular Tachycardia Ablation vs. Enhanced Drug Therapy in Structural Heart Disease

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Appropriate ICD shocks,VT storm and death [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: May 2009
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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

Contacts
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

Locations
Canada, Nova Scotia
QEII Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: John L Sapp, MD, FRCPC    902-473-4272    sappj@cdha.nshealth.ca   
Contact: Karen A Giddens, RDMS, RDCS    902-473-2758    karen.giddens@cdha.nshealth.ca   
Principal Investigator: John L Sapp, MD, FRCPC         
Sub-Investigator: Ratika Parkash, MD, FRCPC         
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 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
  More Information

No publications provided

Responsible Party: John Sapp, Staff physician, Division of Cardiology, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00905853     History of Changes
Other Study ID Numbers: Sapp001
Study First Received: May 20, 2009
Last Updated: March 31, 2014
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
Ventricular Tachycardia
Catheter Ablation
ICD therapy
Antiarrhythmic Drug Therapy
Ischemic Heart Disease

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 29, 2014