Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks
Recurrent ICD shocks are a serious problem in pts with ICD. Treatment failure with other antiarrhythmics and ablation are common. Dronedarone is a new antiarrhythmic drug with ion channel properties similar to amiodarone.
Several case reports have shown promising results with Dronedarone for this patient population.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dronedarone for Patients With Recurrent ICD Shocks Due to Ventricular Arrhythmia Resistant to Their Antiarrhythmic Drug Therapy or Ablation|
- Number of ICD shocks due to VT in the 6 months period after starting Dronedarone [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Drug: Dronedarone arm
PO Dronedarone 400 mg BIDDrug: Dronedarone
Dronedarone PO 400 MG BID