Phase 4
N=100
The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock
Ventricular Tachycardia · Ventricular Fibrillation · Atrial Fibrillation · Supraventricular Tachycardia
Bottom Line
View on ClinicalTrials.gov: NCT00787800 ↗Enrolled (actual)
100
Serious AEs
16.0%
Results posted
Jun 2014
Primary outcome: Primary: Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD) — 1; 1 Participants — p=1.0
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dual Chamber ICD (Device); Single Chamber ICD (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD) |
1; 1 | 1.0 |
| SECONDARY Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes |
37; 0 | — |
| SECONDARY Number of Appropriate Shocks by ICD |
31; 1 | 0.050 |
| SECONDARY Total Cost of ICD Implantation Procedure |
16,579; 14,249 | — |
| SECONDARY Number of Subjects With Newly Detected Atrial Tachyarrhythmias |
12; 0 | <0.001 sig |
| SECONDARY Atrial Fibrillation (AF) Burden |
0.02; 0 | — |
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)
Data sourced from ClinicalTrials.gov (NCT00787800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.