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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ventricular Tachycardia, Ventricular Fibrillation, Atrial Fibrillation, Supraventricular Tachycardia

Intervention / Treatment
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* Device: Dual Chamber ICD
* Device: Single Chamber ICD


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dual Chamber ICD<br>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<br>* 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.<br>* Other names: Virtuoso DR D154AWG;|
| Active Comparator: Single Chamber ICD<br>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<br>* 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.<br>* Other names: Virtuoso VR D154VWC;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shock prevention, Single vs. Dual Chamber, Reduce ventricular pacing, Atrial Fibrillation, Remote Monitoring, ICD, Implantable Cardioverter Defibrillator