NCT03988946
Completed
Not Applicable
Cephea Mitral Valve and Transseptal Delivery System FIH
Cephea Valve Technologies1 site in 1 country1 target enrollmentAugust 1, 2018
ConditionsMitral Regurgitation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Regurgitation
- Sponsor
- Cephea Valve Technologies
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Safety as measured by freedom from major adverse events
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety as measured by freedom from major adverse events
Time Frame: 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
Time Frame: 30 days
Reduction in mitral regurgitation to ≤1+
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Not Applicable
To Evaluate the Efficacy and Safety of the Transfemoral Mitral Valve Repair System in the Treatment of Patients With Moderately Severe and Severe Functional Mitral Regurgitation(FMR) Who Remained Clinically Symptomatic After Guideline-directed Medical TreatmentMitral Valve InsufficiencyNCT05508438Pan Xiangbin140
Not yet recruiting
Not Applicable
Munich Transcatheter Mitral Valve Safety and EffectivenessMitral RegurgitationMitral Valve DiseaseNCT05871983P+F Products + Features GmbH60
Enrolling By Invitation
Not Applicable
Safety and Effectiveness Study of SQ-Kyrin TMVr System for Degenerated Mitral RegurgitationDegenerated Mitral RegurgitationNCT06467110Shanghai Shenqi Medical Technology Co., Ltd118
Recruiting
Not Applicable
Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)Mitral Valve DiseaseNCT04954404Second Affiliated Hospital, School of Medicine, Zhejiang University2,000
Active, not recruiting
Not Applicable
Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral RegurgitationFunctional Mitral RegurgitationNCT05988450Shanghai Shenqi Medical Technology Co., Ltd125