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

Phase 4

Completed

• Conditions: Ventricular Tachycardia; Atrial Fibrillation; Ventricular Fibrillation; Supraventricular Tachycardia
• Interventions: Device: Dual Chamber ICD; Device: Single Chamber ICD

• Registration Number: NCT00787800
• Lead Sponsor: Mayo Clinic

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-06
• Study First Submitted QC: 2008-11-06
• Study First Posted: 2008-11-10
• Primary Completion: 2010-12
• Study Completion: 2011-12
• Results First Submitted: 2013-05-21
• Results First Submitted QC: 2014-06-08
• Results First Posted: 2014-06-11
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-02
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual Chamber ICD	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.
Single Chamber ICD	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD)	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

Name	Time	Method
Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes	Baseline to 12 Months	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	Baseline to 12 Months	Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm.
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	AF burden is defined as the sum of duration of all atrial arrhythmias divided by total observation time, reported as a percentage value.

Trial Locations

Locations (3)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

Carmel Medical Center; 🇮🇱 Haifa, Israel

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States