Status:
UNKNOWN
MitralStitch Mitral Valve Repair System for Mitral Regurgitation
Lead Sponsor:
Xijing Hospital
Conditions:
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective is to assess the effectiveness and safety of the MitralStitch repair system in patients with moderate to severe and severe mitral regurgitation.
Eligibility Criteria
Inclusion
- The age of patient is ≥18yrs;
- Severe mitral regurgitation patients (The area of central regurgitation exceeds 40% of left atrial area or holosystolic eccentric regurgitation; VC≥0.07cm；regurgitant volume ≥60ml；RF ≥50%; EROA≥0.4cm2 (Satisfy any condition).
- LVESD≤60mm, LVEF≥25%, small incision surgery of chest can be tolerated.
- The subject was informed of the clinical application nature of the new technology and agreed to participate in all requirements of the clinical application of the new technology, signed the ICF and agreed to complete the follow-up and the inspection required during the follow-up period.
Exclusion
- Subject who are pregnant, lactating or scheduled to pregnant during the period of the clinical new technology.
- Subjects with active endocarditis or rheumatic mitral valve disease.
- Life expectancy \<1 year for cardiac or other malignant tumors.
- Participate in other clinical trial
- In the judgment of the investigator, subjects had poor acceptance of chemotherapy, and they cannot complete the trial as required.
Key Trial Info
Start Date :
August 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04061837
Start Date
August 23 2019
End Date
October 31 2021
Last Update
August 28 2019
Active Locations (1)
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1
Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032