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

Completed · Phase 4

Conditions studied: Ventricular Tachycardia, Ventricular Fibrillation, Atrial Fibrillation, Supraventricular Tachycardia

In brief

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

Key facts

Study ID

NCT00787800

Run by

Mayo Clinic

People needed

100

Starts

2008-11-01

Expected to finish

2011-12-01

Last updated by the study team

2014-07-24

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Mayo Clinic — Jacksonville, Florida, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Carmel Medical Center — Haifa, Israel
• Sheba Medical Center — Ramat Gan, Israel

Full record on ClinicalTrials.gov

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