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Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

This study is not yet open for participant recruitment. (see Contacts and Locations)
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:


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
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

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
Amiodarone
Anti-Arrhythmia Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 20, 2014