NCT00787800

The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock

Reduction And Prevention of Tachyarrhythmias and Shocks Using Reduced Ventricular Pacing With Atrial Algorithms (The RAPTURE Study)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Ventricular Tachycardia
• Ventricular Fibrillation
• Atrial Fibrillation
• Supraventricular Tachycardia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-12-01
• Completion: 2011-12-01
• First posted: 2008-11-10
• Last updated: 2014-07-24
• Results posted: 2014-06-11

Locations

4 sites across 2 countries: United States, Israel