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Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

This study is not yet open for participant recruitment.
Verified September 2011 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
moti haim, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01430806
First received: September 7, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: moti haim, Director, Electrophysiology Service,, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01430806     History of Changes
Other Study ID Numbers: 6402
Study First Received: September 7, 2011
Last Updated: September 7, 2011
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Shock
Pathologic Processes
Anti-Arrhythmia Agents
Amiodarone
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on June 17, 2013