The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock
Condition: Ventricular Tachycardia; Ventricular Fibrillation; Atrial Fibrillation; Supraventricular Tachycardia
MeSH terms: Atrial Fibrillation; Tachycardia; Tachycardia, Ventricular; Ventricular Fibrillation; Tachycardia, Supraventricular
Intervention: Dual Chamber ICD; Single Chamber ICD
Intervention description: 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: 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Shock prevention; Single vs. Dual Chamber; Reduce ventricular pacing; Atrial Fibrillation; Remote Monitoring; ICD; Implantable Cardioverter Defibrillator

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
    

Eligibility criteria:

        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)