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Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

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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
Information provided by (Responsible Party):
moti haim, 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.

Condition or disease Intervention/treatment
ICD ICD SHOCKS DRONEDARONE Drug: Dronedarone arm Drug: Dronedarone

Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
Drug Information available for: Dronedarone
U.S. FDA Resources

Arm Intervention/treatment
Dronedrone Arm Drug: Dronedarone arm
PO Dronedarone 400 mg BID
Drug: Dronedarone
Dronedarone PO 400 MG BID

Primary Outcome Measures :
  1. Number of ICD shocks due to VT in the 6 months period after starting Dronedarone [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Recurernt ICD shocks depite other antiarrhythmic drug therapy

Exclusion Criteria:


Responsible Party: moti haim, Director, Electrophysiology Service,, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01430806     History of Changes
Other Study ID Numbers: 6402
First Posted: September 8, 2011    Key Record Dates
Last Update Posted: September 8, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Pathologic Processes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors