Programming Implantable Cardioverter Defibrillators in Patients With Primary Prevention Indication
- Conditions
- Shock
- Interventions
- Device: ICD/ CRT-D
- Registration Number
- NCT00743522
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
Although shock therapy is effective in terminating ventricular tachycardia (VT), it can be painful to the patient and repetitive shocks can decrease a patient's quality of life. Previous studies have suggested that one or more sets of aggressive device parameter settings may reduce the total number of shocks in primary prevention patients. In addition to shock therapies, antitachycardia pacing (ATP) is also available in ICDs to treat VT. The PROVIDE trial aims to prospectively study the effect of high detection rates, prolonged detection intervals, aggressive SVT discriminators, and extensive ATP therapy in prolonging the time to first shock in primary prevention patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1670
- Primary Prevention indication for ICD/ CRT-D
- No prior documented history of spontaneous VT/VF
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control ICD/ CRT-D PROVE Trial settings Experimental ICD/ CRT-D Pre-selected settings
- Primary Outcome Measures
Name Time Method The primary endpoint of this study is the rate of first shock Average follow-up period is 530 days The primary safety endpoint of this study is the rate of arrhythmic syncope Average follow-up period is 530 days
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (1)
Hall-Garcia Cardiology Associates
🇺🇸Houston, Texas, United States