Single-arm study for assessment of safety and effectiveness of the ultracompact extracorporeal membrane oxygenation (ECMO) system (BR13030) use as a long-term cardiopulmonary support for severe heart and/or respiratory failure: study protocol for multiple-center, single-arm non-randomized, uncontrolled, and investigator-initiated clinical trial
Phase 3
- Registration Number
- JPRN-UMIN000039474
- Lead Sponsor
- ational Cerebral and Cardiovascular Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
Exclusion Criteria
1) Unfavorable or technically-challenging cardiac anatomy 2) Evidence of irreversible hepatic disease (except when the primary investigator deems it as a sign of acute heart failure) 3) Evidence of irreversible renal disease (except when the primary investigator deems it as a sign of acute heart failure) 4) Contraindicated for anticoagulation 5) Difficulty of 14-day observation is anticipated 6) Participating in another clinical trial at time of study entry 7) Deemed unsuitable by the primary investigator for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method