Ventricular Tachycardia (VT) Ablation Versus Enhanced Drug Therapy
Information source: Capital District Health Authority, Canada
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Recurrent Ventricular Tachycardia
Intervention: Catheter Ablation (Procedure); Aggressive Antiarrhythmic Therapy (Amiodarone) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Capital District Health Authority, Canada Official(s) and/or principal investigator(s):
Anthony S.L. Tang, BSc, MD, FRCP(C), Study Director, Affiliation: Royal Jubilee Hospital
George A. Wells, BSc,MSc,PhD, Study Director, Affiliation: University of Ottawa Heart Institute
Overall contact:
John L Sapp, BSc., M.D., FRCP(C), Phone: 902-473-4272, Email: sappj@cdha.nshealth.ca
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.
Clinical Details
Official title: Ventricular Tachycardia Ablation vs. Enhanced Drug Therapy in Structural Heart Disease
Study design: Cohort, Prospective
Primary outcome: Appropriate ICD shocks and death
Secondary outcome: All cause mortality
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
- Appropriate ICD therapy or sustained VT occurred on another antiarrhythmic drug
- An antiarrhythmic drug other than amiodarone was previously ineffective or not
tolerated
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
Locations and Contacts
John L Sapp, BSc., M.D., FRCP(C), Phone: 902-473-4272, Email: sappj@cdha.nshealth.ca
QEII Health Sciences Centre, Halifax, Nova Scotia B3H 3A7, Canada; Recruiting
John L Sapp, MD, FRCPC, Phone: 902-473-4272, Email: sappj@cdha.nshealth.ca
Karen A Giddens, RDMS, RDCS, Phone: 902-473-2758, Email: karen.giddens@cdha.nshealth.ca
John L Sapp, MD, FRCPC, Principal Investigator
Ratika Parkash, MD, FRCPC, Sub-Investigator
Additional Information
Starting date: May 2009
Ending date: December 2014
Last updated: September 17, 2009
|
