Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

Not Applicable

• Conditions: ICD; ICD SHOCKS; DRONEDARONE
• Interventions: Drug: Dronedarone arm; Drug: Dronedarone

• Registration Number: NCT01430806
• Lead Sponsor: Rabin Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-09
• Study First Submitted: 2011-09-07
• Study First Submitted QC: 2011-09-07
• Last Update Submitted: 2011-09-07
• Study First Posted: 2011-09-08
• Last Update Posted: 2011-09-08
• Study Start: 2011-10
• Primary Completion: 2014-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Recurernt ICD shocks depite other antiarrhythmic drug therapy

Exclusion Criteria

• CHF NYHA IV OR DECMPENSATED III
• PERMANENT AF
• LIVER DYSFUNCION
• CR CLEARANCE <30

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dronedrone Arm	Dronedarone arm	-
Dronedrone Arm	Dronedarone	-

Primary Outcome Measures

Name	Time	Method
Number of ICD shocks due to VT in the 6 months period after starting Dronedarone	1 year