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

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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Ventricular Fibrillation; Ventricular Tachycardia; Supraventricular Tachycardia
• Intervention / Treatment: Device: Dual Chamber ICD; Device: Single Chamber ICD

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Carmel Medical Center
  • Ramat Gan, Israel
    • Sheba Medical Center
• United States
  • Florida
    • Jacksonville, Florida, United States
      • Mayo Clinic
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Virtuoso VR D154VWC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD)	An inappropriate shock is defined as a shock delivered by the ICD during a rhythm other than sustained VT/VF (ventricular tachycardia/ventricular fibrillation).	Baseline to 12 months after ICD implantation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Medtronic
• Investigators: Principal Investigator: Paul A Friedman, MD, Mayo Clinic

Publications and helpful links

General 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. doi: 10.1046/j.1540-8167.2001.00134.x.
• 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. doi: 10.1161/CIRCULATIONAHA.105.594531. 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. doi: 10.1016/j.ijcard.2007.02.041. Epub 2007 Apr 18.
• 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. doi: 10.1056/NEJMoa071880.
• 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.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: November 6, 2008
• First Submitted That Met QC Criteria: November 6, 2008
• First Posted (Estimate): November 10, 2008

Study Record Updates

• Last Update Posted (Estimate): July 24, 2014
• Last Update Submitted That Met QC Criteria: July 2, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; ICD; Remote Monitoring; Implantable Cardioverter Defibrillator; Shock prevention; Single vs. Dual Chamber; Reduce ventricular pacing
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Atrial Fibrillation; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular; Tachycardia, Supraventricular
• Other Study ID Numbers: 08-003618