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| Sponsor: | Capital District Health Authority, Canada |
|---|---|
| Collaborators: |
St. Jude Medical Biosense Webster, Inc. |
| Information provided by: | Capital District Health Authority, Canada |
| ClinicalTrials.gov Identifier: | NCT00905853 |
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 |
| Estimated Enrollment: | 260 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | May 2014 (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:
|
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 |
Patients with ischemic heart disease presenting with appropriate ICD therapy for ventricular tachycardia in spite of first-line antiarrhythmic drug therapy.
Inclusion Criteria:
One of the following VT events (within the past 3 months):
"Failed" first-line antiarrhythmic drug therapy as defined by one of:
Exclusion Criteria:
Contacts and Locations| 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 |
| 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 | |
| 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
| Responsible Party: | Dr. John Sapp, Staff Cardiologist, Capital District Health Authority |
| ClinicalTrials.gov Identifier: | NCT00905853 History of Changes |
| Other Study ID Numbers: | Sapp001 |
| Study First Received: | May 20, 2009 |
| Last Updated: | June 21, 2011 |
| Health Authority: | Canada: Health Canada |
|
Ventricular Tachycardia Catheter Ablation ICD therapy Antiarrhythmic Drug Therapy Ischemic Heart Disease |
|
Heart Diseases Tachycardia Tachycardia, Ventricular Cardiovascular Diseases Arrhythmias, Cardiac Pathologic Processes Amiodarone |
Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents |