Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

• Sponsor: Rabin Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01430806
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Duration (Months): 50

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ICD; ICD SHOCKS; DRONEDARONE	Drug: Dronedarone arm; Drug: Dronedarone	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Oct 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2014
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Dronedrone Arm	Drug: Dronedarone arm; PO Dronedarone 400 mg BID; Drug: Dronedarone; Dronedarone PO 400 MG BID

Outcome Measures

Primary Outcome Measures

1. Number of ICD shocks due to VT in the 6 months period after starting Dronedarone [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Rabin Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: moti haim, Director, Electrophysiology Service,, Rabin Medical Center
• ClinicalTrials.gov Identifier: NCT01430806
• Other Study ID Numbers: 6402
• First Posted: Sep 8, 2011
• Last Update Posted: Sep 8, 2011
• Last Verified: Sep 1, 2011

• Additional relevant MeSH terms: Shock; Dronedarone

Study Results

No Results Posted as of Sep 8, 2011