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Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by moti haim, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
moti haim, Rabin Medical Center Identifier:
First received: September 7, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted

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 Intervention
ICD ICD SHOCKS DRONEDARONE Drug: Dronedarone arm Drug: Dronedarone

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by moti haim, Rabin Medical Center:

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

Estimated Enrollment: 20
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dronedrone Arm Drug: Dronedarone arm
PO Dronedarone 400 mg BID
Drug: Dronedarone
Dronedarone PO 400 MG BID


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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: moti haim, Director, Electrophysiology Service,, Rabin Medical Center Identifier: NCT01430806     History of Changes
Other Study ID Numbers: 6402
Study First Received: September 7, 2011
Last Updated: September 7, 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 processed this record on August 21, 2017