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

NCT00787800 | Completed Phase 4 Results

• 1 other identifier: 08-003618
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 4

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

Conditions

Ventricular Tachycardia; Ventricular Fibrillation; Atrial Fibrillation; Supraventricular Tachycardia

Keywords

Shock prevention; Single vs. Dual Chamber; Reduce ventricular pacing; Atrial Fibrillation; Remote Monitoring; ICD; Implantable Cardioverter Defibrillator

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes

  Baseline to 12 Months

• Number of Appropriate Shocks by ICD

  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

  Implantation through 1 year

Study Arms (2)

Dual Chamber ICD

ACTIVE COMPARATOR

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

Single Chamber ICD

ACTIVE COMPARATOR

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

Interventions

Dual Chamber ICD DEVICE

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.

Also known as: Virtuoso DR D154AWG

Dual Chamber ICD

Single Chamber ICD DEVICE

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.

Also known as: Virtuoso VR D154VWC

Single Chamber ICD

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Medtronic: collaborator

Study Sites (4)

Mayo Clinic

Jacksonville, Florida, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Carmel Medical Center

Haifa, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Related Publications (5)

• 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.

  PMID: 11232608 BACKGROUND

• 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.

  PMID: 16769912 BACKGROUND

• 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.

  PMID: 17445918 BACKGROUND

• 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.

  PMID: 17804844 BACKGROUND

• 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.

  PMID: 24928948 BACKGROUND

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation; Atrial Fibrillation; Tachycardia, Supraventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Paul A. Friedman, MD, Professor of Medicine
• Organization: Mayo Clinic

friedman.paul@mayo.edu

507-284-7661

Study Officials

• Paul A Friedman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 10, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: July 24, 2014
• Results First Posted: June 11, 2014

Record last verified: 2014-07

Locations

IL (2); US (2)