Ventricular Tachycardia (VT) Ablation Versus Enhanced Drug Therapy (VANISH)
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.
Recurrent Ventricular Tachycardia
Procedure: Catheter Ablation
Drug: Aggressive Antiarrhythmic Therapy (Amiodarone)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Ventricular Tachycardia Ablation vs. Enhanced Drug Therapy in Structural Heart Disease|
- Appropriate ICD shocks,VT storm and death [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- All cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|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)|
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 AblationDrug: 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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905853
|Contact: John L Sapp, BSc., M.D., FRCP(C)||email@example.com|
|Contact: Ratika Parkash, MD, MSc, FRCP(C)||firstname.lastname@example.org|
|Canada, Nova Scotia|
|QEII Health Sciences Centre||Recruiting|
|Halifax, Nova Scotia, Canada, B3H 3A7|
|Contact: John L Sapp, MD, FRCPC 902-473-4272 email@example.com|
|Contact: Karen A Giddens, RDMS, RDCS 902-473-2758 firstname.lastname@example.org|
|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|