Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy (VANISH)
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|ClinicalTrials.gov Identifier: NCT00905853|
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : July 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Ventricular Tachycardia||Procedure: Catheter Ablation Drug: Escalated Antiarrhythmic Therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ventricular Tachycardia Ablation or Escalated aNtiarrhythmic Drugs in ISchemic Heart Disease|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
U.S. FDA Resources
Active Comparator: Ventricular Tachycardia Ablation
Catheter ablation for Ventricular tachycardia will be performed within 14 days of randomization.
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
Active Comparator: Escalated Antiarrhythmic Drug Therapy
Patients are prescribed a loading dose of amiodarone or the addition of mexiletine to their current anti-arrhythmic medication which is stratified by the dose and type of antiarrhymic medication at the time of the index arrhythmic event.
Drug: Escalated Antiarrhythmic Therapy
Patients who have 'failed' antiarrhythmic therapy (except amiodarone) will be prescribed: 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) will be prescribed: 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) will be prescribed: Amiodarone at the current dose with the addition of mexiletine 400 to 800 mg/day
- Appropriate ICD shocks,VT storm and death [ Time Frame: 3 years ]
- All cause mortality [ Time Frame: 3 years ]
- Appropriate ICD antitachycardia pacing anytime and after 1 month treatment period [ Time Frame: 3 years ]
- appropriate ICD shocks anytime and after 1 month treatment period [ Time Frame: 3 years ]
- Inappropriate shocks anytime and after 1 month treatment period [ Time Frame: 3 years ]
- VT storm anytime and after 1 month treatment period [ Time Frame: 3 years ]
- Documented sustained VT below detection rate of the ICD any time and after 1 month treatment period [ Time Frame: 3 years ]
- Number of ICD shocks [ Time Frame: 3 years ]
- Hospital admission for cardiac causes [ Time Frame: 3 years ]
- Procedural complications, amiodarone toxicity or adverse events [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905853
|Canada, Nova Scotia|
|QEII Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3H 3A7|
|Principal Investigator:||John L Sapp, BSc, MD, FRCPC||Nova Scotia Health Authority|
|Study Director:||Ratika Parkash, MD, MSc, FRCPC||Nova Scotia Health Authority|
|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|