Clinical Trials Logo
  1. Home
  2. ICD
  3. NCT01430806
  4. Details
NCT01430806 Clinical Trial

Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

ICD Clinical Trial

Official title:
Dronedarone for Patients With Recurrent ICD Shocks Due to Ventricular Arrhythmia Resistant to Their Antiarrhythmic Drug Therapy or Ablation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01430806
Other study ID # 6402
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 7, 2011
Last updated September 7, 2011
Start date October 2011
Est. completion date December 2015

Study information
Verified date September 2011
Source Rabin Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date December 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Dronedarone arm
PO Dronedarone 400 mg BID
• Dronedarone
Dronedarone PO 400 MG BID

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Number of ICD shocks due to VT in the 6 months period after starting Dronedarone 1 year Yes
See also
  Status Clinical Trial Phase
Recruiting NCT05048602 - Drug-induced Brugada Syndrome Research Database
Completed NCT04055740 - Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction N/A
Completed NCT02877693 - A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging N/A
Completed NCT00890461 - Reconstruction of 12-Lead Electrogram From Intracardiac Signals From Defibrillators During or After Implantation N/A
Completed NCT03366181 - Anti Arrhythmic Therapies and Sudden Cardiac Deaths
Completed NCT02713360 - Screening and Intervention Reducing Anxiety in Patients With Implanted Cardioverter Defibrillator (ICD) N/A
Completed NCT06068699 - Postcards to Improve Remote Monitoring Adherence Among Veterans N/A
Completed NCT01594112 - Ability of Home Monitoring® to Detect and Manage the Inappropriate Diagnoses in Implantable Cardioverter Defibrillators. N/A
Recruiting NCT03357926 - Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
Active, not recruiting NCT04590144 - Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO) N/A
Active, not recruiting NCT05361681 - EMI and CIED: Is High Power Charging of Battery Electric Car Safe? N/A
Active, not recruiting NCT04505007 - Guideline-Directed Medical Therapy in Patients After Implantation of Implantable Cardioverter Defibrillators to Improve Long-Term Outcomes N/A
Active, not recruiting NCT04981496 - Novel ICD Arrhythmia Detection Algorithm
Completed NCT04014946 - Assessment of Risk Factors for Appropriate ICD (Implantable Cardioverter-defibrillator) Intervention in Patients With Ischemic Cardiomyopathy N/A
Completed NCT02693262 - Comparing Rate Response With CLS Versus Accelerometer ICD Settings in Heart Failure Patients With BIOTRONIK CRT-Ds N/A
Recruiting NCT05072119 - Monaldi Hospital Rhythm Registry
Completed NCT00652522 - Atrial Fibrillation Management in Congestive Heart Failure With Ablation N/A
Recruiting NCT05835791 - END - VT Cohort Study
Active, not recruiting NCT04284800 - Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Undergoing Defibrillation Threshold Testing
Withdrawn NCT04678128 - Dance4Healing: Explore the Benefits of Tele-Dance in Individuals With an Implantable Cardioverter-defibrillator (ICD) N/A