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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
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.
Mayo Clinic
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Carmel Medical Center
Haifa, Israel
Sheba Medical Center
Ramat Gan, Israel
Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD)
An inappropriate shock is defined as a shock delivered by the ICD during a rhythm other than sustained VT/VF (ventricular tachycardia/ventricular fibrillation).
Time frame: Baseline to 12 months after ICD implantation
Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes
Episodes of Atrial Fibrillation (AF) or Atrial Flutter (AFL) greater than 5 minutes duration. A subject may experience multiple episodes.
Time frame: Baseline to 12 Months
Number of Appropriate Shocks by ICD
Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm.
Time frame: Baseline to 12 Months
Total Cost of ICD Implantation Procedure
Time frame: Baseline
Number of Subjects With Newly Detected Atrial Tachyarrhythmias
Time frame: Baseline to 12 months after ICD implantation
Atrial Fibrillation (AF) Burden
AF burden is defined as the sum of duration of all atrial arrhythmias divided by total observation time, reported as a percentage value.
Time frame: Implantation through 1 year
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