The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock (RAPTURE)
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Ventricular Tachycardia Ventricular Fibrillation Atrial Fibrillation Supraventricular Tachycardia |
Device: ICD |
Phase 4 |
| Study Type: | Interventional |
| 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) |
- Rate of inappropriate shock per unity time follow up. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Improved quality of life, reduced health care expenditure, reduced burden of atrial fibrillation, incremental cost-effectiveness of dual versus single chamber ICDs in dollars per quality adjusted life year gained. [ Time Frame: 12 month ] [ Designated as safety issue: No ]
| Enrollment: | 100 |
| Study Start Date: | November 2008 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
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.
|
Device: ICD
Arm 1 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. Arm 2 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 Names:
|
|
Active Comparator: 2
Single chamber: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
|
Device: ICD
Arm 1 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. Arm 2 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 Names:
|
Detailed Description:
While 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 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 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.
Patient's will complete a baseline sleep study questionnaire. QOL and health care utilization surveys will be completed at each visit. Device interrogations will be performed at the 3 and 12 month visit. Carelink transmissions performed at 6 and 9 months.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- Candidates for ICD for primary prevention according to AHA/ACC guidelines who have a clinical indication for ICD implantation for ventricular arrhythmia or sudden death prevention.
The ability to understand the scope of the study, provide written informed consent, and a willingness to complete all study visits and associated procedures.
-
Exclusion Criteria:
- Pregnant women
- Age <18 years old
- Inability to provide consent
- On a heart transplant list
- Life expectancy <1 year
- Mobitz II or higher heart block
- AV node ablation
- Permanent atrial fibrillation or atrial flutter
- Indication for cardiac resynchronization
- Preexisting, separate pacemaker pulse generator that won't be explanted
- Intra-aortic balloon pump or other device
- Inotropic drug (not digitalis) necessary for hemodynamic support
- Chronic serious bacterial infection
- Inability to receive pectoral non-thoracotomy lead ICD
- Inability to program device according to protocol -
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Dr. Paul Friedman, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00787800 History of Changes |
| Other Study ID Numbers: | 08-003618 |
| Study First Received: | November 6, 2008 |
| Last Updated: | December 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
Reduce shocks Reduce ventricular pacing Atrial Fibrillation Remote Monitoring |
Additional relevant MeSH terms:
|
Atrial Fibrillation Shock Tachycardia Tachycardia, Supraventricular Ventricular Fibrillation |
Tachycardia, Ventricular Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013