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

Atrial Fibrillation Clinical Trial

— RAPTURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00787800
• Other study ID #: 08-003618
• Status: Completed
• Phase: Phase 4
• First received: November 6, 2008
• Last updated: July 2, 2014
• Start date: November 2008
• Est. completion date: December 2011

Study information

• Verified date: July 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Supraventricular Tachycardia
• Tachycardia
• Tachycardia, Supraventricular
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa
Israel	Sheba Medical Center	Ramat Gan
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Medtronic

Countries where clinical trial is conducted

United States,  Israel, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Number of Appropriate Shocks by ICD	Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm.	Baseline to 12 Months	No
Secondary	Total Cost of ICD Implantation Procedure		Baseline	No
Secondary	Number of Subjects With Newly Detected Atrial Tachyarrhythmias		Baseline to 12 months after ICD implantation	No
Secondary	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	No

External Links

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