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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00787800
First received: November 6, 2008
Last updated: December 15, 2011
Last verified: December 2011
  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)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Rate of inappropriate shock per unity time follow up. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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:
  • Virtuoso DR D154AWG
  • Virtuoso VR D154VWC
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:
  • Virtuoso DR D154AWG
  • Virtuoso VR D154VWC

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
Criteria
  1. 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.
  2. 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:

  1. Pregnant women
  2. Age <18 years old
  3. Inability to provide consent
  4. On a heart transplant list
  5. Life expectancy <1 year
  6. Mobitz II or higher heart block
  7. AV node ablation
  8. Permanent atrial fibrillation or atrial flutter
  9. Indication for cardiac resynchronization
  10. Preexisting, separate pacemaker pulse generator that won't be explanted
  11. Intra-aortic balloon pump or other device
  12. Inotropic drug (not digitalis) necessary for hemodynamic support
  13. Chronic serious bacterial infection
  14. Inability to receive pectoral non-thoracotomy lead ICD
  15. Inability to program device according to protocol -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787800

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Medtronic
Investigators
Principal Investigator: Paul A Friedman, MD Mayo Clinic
  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 April 17, 2014