Cephea Transseptal Mitral Valve System FIH
- Conditions
- Mitral Regurgitation
- Registration Number
- NCT03988946
- Lead Sponsor
- Cephea Valve Technologies
- Brief Summary
To assess the safety and performance of the Cephea Transseptal Mitral Valve System for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety as measured by freedom from major adverse events 30 days Freedom from major adverse events, including:
* All-cause mortality
* Disabling stroke
* Myocardial infarction
* Renal failure requiring dialysis
* Life-threatening bleeding
* Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention.Performance 30 days Reduction in mitral regurgitation to ≤1+
- 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)
St. Vincent's Hospital
🇦🇺Sydney, New South Wales, Australia
St. Vincent's Hospital🇦🇺Sydney, New South Wales, Australia