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 (Responsible Party):
Paul A. Friedman, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00787800
First received: November 6, 2008
Last updated: July 2, 2014
Last verified: July 2014
  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: Dual Chamber ICD
Device: Single Chamber 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:
  • 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).


Secondary Outcome Measures:
  • 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.


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: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidates for ICD for primary prevention according to American Heart Association/American College of Cardiology (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 waiting list
  • Life expectancy <1 year
  • Indication for pacing
  • Atrioventricular (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
  • History of Out of Hospital Cardiac Arrest (OHCA) or sustained Ventricular Tachycardia as an indication for ICD (secondary prevention indication)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787800

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Israel
Carmel Medical Center
Haifa, Israel
Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
Mayo Clinic
Medtronic
Investigators
Principal Investigator: Paul A Friedman, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Paul A. Friedman, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00787800     History of Changes
Other Study ID Numbers: 08-003618
Study First Received: November 6, 2008
Results First Received: May 21, 2013
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Shock prevention
Single vs. Dual Chamber
Reduce ventricular pacing
Atrial Fibrillation
Remote Monitoring
ICD
Implantable Cardioverter Defibrillator

Additional relevant MeSH terms:
Atrial Fibrillation
Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014