Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks
Dronedarone for Patients With Recurrent ICD Shocks Due to Ventricular Arrhythmia Resistant to Their Antiarrhythmic Drug Therapy or Ablation
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2011
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2011
CompletedFirst Posted
Study publicly available on registry
September 8, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedSeptember 8, 2011
September 1, 2011
3.2 years
September 7, 2011
September 7, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Number of ICD shocks due to VT in the 6 months period after starting Dronedarone
1 year
Study Arms (1)
Dronedrone Arm
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Recurernt ICD shocks depite other antiarrhythmic drug therapy
You may not qualify if:
- CHF NYHA IV OR DECMPENSATED III
- PERMANENT AF
- LIVER DYSFUNCION
- CR CLEARANCE \<30
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Electrophysiology Service,
Study Record Dates
First Submitted
September 7, 2011
First Posted
September 8, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2015
Last Updated
September 8, 2011
Record last verified: 2011-09