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NCT01430806 Clinical Trial

Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

ICD Clinical Trial

Official title:
Dronedarone for Patients With Recurrent ICD Shocks Due to Ventricular Arrhythmia Resistant to Their Antiarrhythmic Drug Therapy or Ablation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01430806
Other study ID # 6402
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 7, 2011
Last updated September 7, 2011
Start date October 2011
Est. completion date December 2015

Study information
Verified date September 2011
Source Rabin Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date December 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Dronedarone arm
PO Dronedarone 400 mg BID
• Dronedarone
Dronedarone PO 400 MG BID

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Number of ICD shocks due to VT in the 6 months period after starting Dronedarone 1 year Yes
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