Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01430806|
Recruitment Status : Unknown
Verified September 2011 by moti haim, Rabin Medical Center.
Recruitment status was: Not yet recruiting
First Posted : September 8, 2011
Last Update Posted : September 8, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|ICD ICD SHOCKS DRONEDARONE||Drug: Dronedarone arm Drug: Dronedarone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dronedarone for Patients With Recurrent ICD Shocks Due to Ventricular Arrhythmia Resistant to Their Antiarrhythmic Drug Therapy or Ablation|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2015|
Drug: Dronedarone arm
PO Dronedarone 400 mg BIDDrug: Dronedarone
Dronedarone PO 400 MG BID
- Number of ICD shocks due to VT in the 6 months period after starting Dronedarone [ Time Frame: 1 year ]