Clinical trial NCT00905853: Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy
Official title: Ventricular Tachycardia Ablation or Escalated aNtiarrhythmic Drugs in ISchemic Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Recurrent Ventricular Tachycardia
Keywords: Ventricular Tachycardia
Catheter Ablation
ICD therapy
Antiarrhythmic Drug Therapy
Ischemic Heart Disease
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
name: Biosense Webster, Inc.
name: Canadian Institutes of Health Research (CIHR)
First posted: 2009-05-21
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Appropriate ICD shocks,VT storm and death
timeFrame: 3 years
Secondary outcomes:
measure: All cause mortality
timeFrame: 3 years
measure: Appropriate ICD antitachycardia pacing anytime and after 1 month treatment period
timeFrame: 3 years
measure: appropriate ICD shocks anytime and after 1 month treatment period
timeFrame: 3 years
measure: Inappropriate shocks anytime and after 1 month treatment period
timeFrame: 3 years
measure: VT storm anytime and after 1 month treatment period
timeFrame: 3 years
measure: Documented sustained VT below detection rate of the ICD any time and after 1 month treatment period
timeFrame: 3 years
measure: Number of ICD shocks
timeFrame: 3 years
measure: Hospital admission for cardiac causes
timeFrame: 3 years
measure: Procedural complications, amiodarone toxicity or adverse events
timeFrame: 3 years
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: John L Sapp, BSc, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Nova Scotia Health Authority
name: Ratika Parkash, MD, MSc, FRCPC
role: STUDY_DIRECTOR
affiliation: Royal Jubilee Hospital
name: Anthony S Tang, MSc, MD, FRCPC
role: STUDY_DIRECTOR
affiliation: Univeristy of Ottawa Heart Institute
name: George A Wells, BSc,MSc,PhD
role: STUDY_DIRECTOR
affiliation: Brigham and Women's Hospital
name: William G Stevenson, MD
role: STUDY_DIRECTOR
References:
citation: Parkash R, Nault I, Rivard L, Gula L, Essebag V, Nery P, Tung S, Raymond JM, Sterns L, Doucette S, Wells G, Tang ASL, Stevenson WG, Sapp JL. Effect of Baseline Antiarrhythmic Drug on Outcomes With Ablation in Ischemic Ventricular Tachycardia: A VANISH Substudy (Ventricular Tachycardia Ablation Versus Escalated Antiarrhythmic Drug Therapy in Ischemic Heart Disease). Circ Arrhythm Electrophysiol. 2018 Jan;11(1):e005663. doi: 10.1161/CIRCEP.117.005663.
citation: 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.