The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock (RAPTURE)
The RAPTURE Study will determine whether dual chamber defibrillators with atrial prevention and termination therapies, minimized ventricular pacing, and remote monitoring will reduce the rate of inappropriate shocks and improve quality of life compared to optimally programmed back-up pacing only single chamber ICDs when used for primary prevention of sudden cardiac death
Device: Dual Chamber ICD
Device: Single Chamber ICD
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Reduction And Prevention of Tachyarrhythmias and Shocks Using Reduced Ventricular Pacing With Atrial Algorithms (The RAPTURE Study)|
- Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD) [ Time Frame: Baseline to 12 months after ICD implantation ] [ Designated as safety issue: No ]An inappropriate shock is defined as a shock delivered by the ICD during a rhythm other than sustained VT/VF (ventricular tachycardia/ventricular fibrillation).
- Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes [ Time Frame: Baseline to 12 Months ] [ Designated as safety issue: No ]Episodes of Atrial Fibrillation (AF) or Atrial Flutter (AFL) greater than 5 minutes duration. A subject may experience multiple episodes.
- Number of Appropriate Shocks by ICD [ Time Frame: Baseline to 12 Months ] [ Designated as safety issue: No ]Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm.
- Total Cost of ICD Implantation Procedure [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Number of Subjects With Newly Detected Atrial Tachyarrhythmias [ Time Frame: Baseline to 12 months after ICD implantation ] [ Designated as safety issue: No ]
- Atrial Fibrillation (AF) Burden [ Time Frame: Implantation through 1 year ] [ Designated as safety issue: No ]AF burden is defined as the sum of duration of all atrial arrhythmias divided by total observation time, reported as a percentage value.
|Study Start Date:||November 2008|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Dual Chamber ICD
Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
Device: Dual Chamber ICD
Dual Chamber ICD: Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation Dual Chamber ICD Atrial prevention and termination therapies, Managed Ventricular Pacing (MVP)along with VT/VF detection and therapies for dual chamber device.
Other Name: Virtuoso DR D154AWG
Active Comparator: Single Chamber ICD
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) detection and therapies will be programmed on including use of detection enhancements.
Device: Single Chamber ICD
Single Chamber: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
VT/VF detection and therapies with discrimination criteria for single chamber device.
Other Name: Virtuoso VR D154VWC
While implantable cardioverter-defibrillator (ICD) therapy has become the gold standard for sudden death prevention in high risk individuals, reduction of device associated morbidity remains a significant problem. Rapidly conducted atrial tachyarrhythmias inappropriately detected as ventricular tachycardia (VT) are the most common cause for inappropriate shocks in ICD recipients, affecting 10 to 40% of patients. Large multicenter trials have shown modest benefits of atrial pacing in preventing atrial fibrillation, however right ventricular (RV) pacing was not limited, thus any favorable effects associated with atrial prevention and treatment may have been offset by the RV pacing. New algorithms to prevent RV pacing are now made available in our current devices. The choice of dual chamber versus single chamber ICD for primary prevention warrants re-assessment of atrial prevention and termination therapies, without the potentially adverse effects of RV pacing.
This Multi Center Pilot study will enroll 100 eligible subjects, 50 to single chamber and 50 to dual chamber ICDs. Patients will be followed for one year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787800
|United States, Florida|
|Jacksonville, Florida, United States|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Carmel Medical Center|
|Sheba Medical Center|
|Ramat Gan, Israel|
|Principal Investigator:||Paul A Friedman, MD||Mayo Clinic|