Status:
COMPLETED
The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Medtronic
Conditions:
Ventricular Tachycardia
Ventricular Fibrillation
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
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 inapp...
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 signifi...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00787800
Start Date
November 1 2008
End Date
December 1 2011
Last Update
July 24 2014
Active Locations (4)
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1
Mayo Clinic
Jacksonville, Florida, United States
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Carmel Medical Center
Haifa, Israel
4
Sheba Medical Center
Ramat Gan, Israel