Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP (APPRAISE-ATP)
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation
- Registration Number
- JPRN-UMIN000029382
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 2600
Not provided
History of spontaneous sustained VT (> or 160 bpm at > or 30 seconds in duration) or VF not due to a reversible cause NYHA Class IV documented in the medical records within 90 calendar days prior to enrollment Subject is eligible and scheduled for cardiac resynchronization (CRT) implant Subjects with a previous subcutaneous ICD (S-ICD) Subject with existing TV-ICD device implanted for greater than 60 days Subjects with coronary artery bypass graft surgery or percutaneous coronary intervention within the past 90 calendar days prior to enrollment Subjects with documented myocardial infarction within the past 90 calendar days prior to enrollment Subjects on the active heart transplant list Subject who has a VAD or is to receive VAD Life expectancy shorter than 18 months due to any medical condition (e.g., cancer, uremia, liver failure, etc...) Subjects currently requiring hemodialysis Subject who is known to pregnant or plans to become pregnant over the course of the trial Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time-to-First All-Cause Shock
- Secondary Outcome Measures
Name Time Method Time-to-First All-Cause Shock or Death from Any Cause Time-to-Death from Any Cause Time-to-First Appropriate Shock Time-to-First Inappropriate Shock