PainFree SST Clinical Study
- Conditions
- Ventriculartachyarrhythmias
- Registration Number
- JPRN-UMIN000005006
- Lead Sponsor
- Medtronic Japan Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 181
Not provided
Patients meeting any of the following criteria cannot be included in the study - Patients with a mechanical tricuspid heart valve - Patients enrolled or intended to participate in any concurrent drug and/or device study, which would confound the results of this trial as determined by Medtronic, during the course of this clinical study - Patients with medical conditions that preclude the testing required for all subjects by the study protocol or that otherwise limit study participation required for all subjects - Patients with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc) - Patients anticipated not being able to complete the study - Patients unwilling to provide written informed consent Patients will be screened to ensure they meet all of the inclusion and none of the exclusion criteria. Institutional Review Board / Medical Ethics Committee / Head of Medical Institution / Helsinki Committee (Ethics Board) approval of the Protecta Clinical Investigation Plan and Informed Consent Form must be obtained prior to enrolling patients in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Objectives - Evaluate the inappropriate shock free rate at one year post-implant for subjects implanted with a DR-ICD or CRT-D device - Evaluate the inappropriate shock free rate at one year post-implant for subjects implanted with a VR-ICD device
- Secondary Outcome Measures
Name Time Method Ancillary Objectives - Demonstrate non-inferiority of syncopal event free rate of VF NID 30/40 versus VF NID 18/24 in secondary prevention subjects - Evaluate the effect of shocks on Quality of Life - Evaluate the effect of shocks on Health Care Utilization - Evaluate the frequency of full syncopal events - Summarize the reasons for inappropriate shocks