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

• ClinicalTrials.gov Identifier: NCT00787800
• Recruitment Status: Completed
• First Posted: November 10, 2008
• Results First Posted: June 11, 2014
• Last Update Posted: July 24, 2014
• Sponsor: Mayo Clinic
• Collaborator: Medtronic
• Information provided by (Responsible Party): Paul A. Friedman, Mayo Clinic

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Ventricular Tachycardia; Ventricular Fibrillation; Atrial Fibrillation; Supraventricular Tachycardia	Device: Dual Chamber ICD; Device: Single Chamber ICD	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Reduction And Prevention of Tachyarrhythmias and Shocks Using Reduced Ventricular Pacing With Atrial Algorithms (The RAPTURE Study)
• Study Start Date: November 2008
• Actual Primary Completion Date: December 2010
• Actual Study Completion Date: December 2011

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD) [ Time Frame: Baseline to 12 months after ICD implantation ]
   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 :

1. Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes [ Time Frame: Baseline to 12 Months ]
   Episodes of Atrial Fibrillation (AF) or Atrial Flutter (AFL) greater than 5 minutes duration. A subject may experience multiple episodes.
2. Number of Appropriate Shocks by ICD [ Time Frame: Baseline to 12 Months ]
   Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm.
3. Total Cost of ICD Implantation Procedure [ Time Frame: Baseline ]
4. Number of Subjects With Newly Detected Atrial Tachyarrhythmias [ Time Frame: Baseline to 12 months after ICD implantation ]
5. Atrial Fibrillation (AF) Burden [ Time Frame: Implantation through 1 year ]
   AF burden is defined as the sum of duration of all atrial arrhythmias divided by total observation time, reported as a percentage value.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

Mayo Clinic Clinical Trials 

Publications:

Deisenhofer I, Kolb C, Ndrepepa G, Schreieck J, Karch M, Schmieder S, Zrenner B, Schmitt C. Do current dual chamber cardioverter defibrillators have advantages over conventional single chamber cardioverter defibrillators in reducing inappropriate therapies? A randomized, prospective study. J Cardiovasc Electrophysiol. 2001 Feb;12(2):134-42.

Friedman PA, McClelland RL, Bamlet WR, Acosta H, Kessler D, Munger TM, Kavesh NG, Wood M, Daoud E, Massumi A, Schuger C, Shorofsky S, Wilkoff B, Glikson M. Dual-chamber versus single-chamber detection enhancements for implantable defibrillator rhythm diagnosis: the detect supraventricular tachycardia study. Circulation. 2006 Jun 27;113(25):2871-9. Epub 2006 Jun 12.

Theuns DA, Rivero-Ayerza M, Boersma E, Jordaens L. Prevention of inappropriate therapy in implantable defibrillators: A meta-analysis of clinical trials comparing single-chamber and dual-chamber arrhythmia discrimination algorithms. Int J Cardiol. 2008 Apr 25;125(3):352-7. Epub 2007 Apr 18. Review.

Sweeney MO, Bank AJ, Nsah E, Koullick M, Zeng QC, Hettrick D, Sheldon T, Lamas GA; Search AV Extension and Managed Ventricular Pacing for Promoting Atrioventricular Conduction (SAVE PACe) Trial. Minimizing ventricular pacing to reduce atrial fibrillation in sinus-node disease. N Engl J Med. 2007 Sep 6;357(10):1000-8.

Friedman PA, Bradley D, Koestler C, Slusser J, Hodge D, Bailey K, Kusumoto F, Munger TM, Militanu A, Glikson M. A prospective randomized trial of single- or dual-chamber implantable cardioverter-defibrillators to minimize inappropriate shock risk in primary sudden cardiac death prevention. Europace. 2014 Oct;16(10):1460-8. doi: 10.1093/europace/euu022. Epub 2014 Jun 13.

• Responsible Party: Paul A. Friedman, MD, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT00787800
• Other Study ID Numbers: 08-003618
• First Posted: November 10, 2008
• Results First Posted: June 11, 2014
• Last Update Posted: July 24, 2014
• Last Verified: July 2014

Keywords provided by Paul A. Friedman, 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; Cardiac Conduction System Disease