A Prospective, Multicenter, Single-Arm Clinical Trial to Assess the Safety and Efficacy of a Transcatheter Mitral Valve Clip Delivery System With Steerable Guide Catheter in Patients With Moderate-Severe or Severe Degenerative Mitral Regurgitation (DMR)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerated Mitral Regurgitation
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- 1. Incidence of composite endpoint of no death, no surgical mitral valve-related procedures due to mitral valve dysfunction, and no moderate-severe or severe MR (MR>2+) at 12 months after surgery
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
Brief Summary
To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd.in patients with moderate-severe or severe degenerated mitral regurgitation (DMR).
Detailed Description
This study is clinical research using a prospective, multicenter, single arm method to evaluate the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter transcatheter mitral valve clip delivery system and steerable guide catheter in the treatment of patients with moderate-severe (3+) or severe (4+) degenerated mitral regurgitation. A total of 118 subjects are planned to be included in this trial. All subjects are treated with transcatheter mitral valve clip delivery system and steerable guide catheter transcatheter mitral valve clip delivery system and steerable guide catheter, and are followed up at 30 days, 6 months and 12 months after surgery. At the follow-up of 12 months after surgery, the composite endpoints of no death, no surgical mitral valve related surgery due to mitral valve dysfunction, and no moderate-severe or severe MR (MR \> 2 +) are evaluated. After the follow-up of 12 months after surgery, the stage statistical analysis, clinical summary and application for product registration are performed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Severe MR ≥3+ as determined by transthoracic echocardiography (TTE);
- •STS risk score results show that patients at high risk for traditional surgery or patients who cannot tolerate traditional thoracotomy: Subjects judged to be refractory to mitral valve surgery due to a ≥ 8% risk of death from STS surgery for surgical mitral valve replacement, or a ≥ 6% risk of death from STS surgery for surgical mitral valve repair, or because of any of the following risk factors:
- •Porcelain aorta or active ascending aortic plaque
- •Mediastinum treated with radiotherapy
- •Past mediastinitis
- •Left ventricular ejection fraction (LVEF) \<40%
- •Presence of a patent coronary bypass implant
- •Acceptance of two or more cardiothoracic surgeries
- •Liver cirrhosis
- •Other surgical risk factors
Exclusion Criteria
- •History of mitral valve surgery;
- •Patients with infective endocarditis or suggestive of active infection;
- •Complicated with severe untreated coronary artery disease;
- •Patients with pulmonary hypertension (pulmonary systolic blood pressure\>70mmHg);
- •Patients with transthoracic echocardiographic evidence suggesting moderate-severe to severe right ventricular dysfunction;
- •Left ventricular ejection fraction \<20%;
- •Patients who are extremely frail and cannot tolerate general anesthesia surgery or is in the state of shock requiring circulatory support;
- •Patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis;
- •Mitral regurgitation due to active rheumatic heart disease or rheumatic etiology;
- •Severe renal insufficiency (eGFR ≤ 25 mL/min) or requiring chronic renal replacement therapy;
Outcomes
Primary Outcomes
1. Incidence of composite endpoint of no death, no surgical mitral valve-related procedures due to mitral valve dysfunction, and no moderate-severe or severe MR (MR>2+) at 12 months after surgery
Time Frame: 12 months after surgery
Incidence of composite endpoint of no death, no surgical mitral valve-related procedures due to mitral valve dysfunction, and no moderate-severe or severe MR (MR\>2+) at 12 months after surgery