Safety and Performance Study of the MitralStitch Repair System.
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Mitral Regurgitation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: The clinical trial was designed as a single group assignment study. The participants with moderate to severe and severe mitral valve regurgitation will receive a transapical beating-heart mitral valve repair surgery using MitralStitchTM mitral valve repair system.Masking: None (Open Label)Masking Description: No maskingPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The clinical trial was designed as a prospective, multicenter, single group assignment study. The participants with moderate to severe and severe mitral valve regurgitation will receive a transapical beating-heart mitral valve repair surgery using MitralStitch mitral valve repair system after signed...
The clinical trial was designed as a prospective, multicenter, single group assignment study. The participants with moderate to severe and severe mitral valve regurgitation will receive a transapical beating-heart mitral valve repair surgery using MitralStitch mitral valve repair system after signed the informed consent. The follow-up will be conducted after 30 days, 3 months, 6 months and 12 months of the operation. The following conditions evaluate the performance of the system and the safety and efficiency of using MitralStitch mitral valve repair system in treating patients with severe mitral regurgitation. The none occurrence of these conditions will be approved as the main validity index: death, mitral valve related surgery without mitral valve failure and moderate or severe mitral regurgitation (MR > 2+). The secondary validity index was technical success rate, instrument success rate, surgical success rate, cardiac function improvement and quality of life improvement. And the safety evaluation indicators were assessed by the incidence of major adverse events, adverse events, serious adverse events, and device defects.
Tracking Information
- NCT #
- NCT04080362
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Shengshou Hu Chinese Academy of Medical Science, Fuwai Hospital