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Prospective, single arm, multi-Center clinical study on the efficacy and safety of mitral valve repair device for mitral regurgitation:

Prospective, single arm, multi-Center clinical study on the efficacy and safety of mitral valve repair device for mitral regurgitation:

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043663
Enrollment
Unknown
Registered
2021-02-25
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mitral regurgitation

Interventions

Single Arm:Surgical

Sponsors

Zhongshan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years old, regardless of gender. 2. Degenerative mitral regurgitation >= 3+. 3. Patients with A2 or P2 prolapse alone. 4. NYHA grade II - IV. 5. Patients with high risk or contraindication to conventional surgery (STS risk score >= 6% or other risk factors) judged by expert committee. 6. Patients who voluntarily participate in and sign informed consent and are willing to complete the trial according to the clinical trial protocol.

Exclusion criteria

Exclusion criteria: 1. Complicated with infective endocarditis. 2. Pregnant women. 3. Patients with vegetations / thrombi in left ventricle, atrium or left atrial appendage. 4. Anticoagulant contraindication patients. 5. Severe calcification of mitral valve leaflet. 6. Severe primary pulmonary hypertension. 7. The thoracic deformity makes it impossible to perform the operation via the apical approach. 8. In addition to ASD and PFO occlusion, patients who require other cardiac surgery at the same time. 9. Patients with ST segment elevation myocardial infarction within 30 days before operation. 10. Left ventricular ejection fraction < 30%. 11. Patients who underwent cardio cerebrovascular and peripheral vascular surgery within 30 days before operation. 12. Severe tricuspid regurgitation. 13. The life expectancy is less than 12 months. 14. The researcher thinks that it is not suitable to participate in this clinical trial. 15. Participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Success rate of mitral valve repair;—

Secondary

MeasureTime frame
Size of Left ventricular and left atrial, left ventricular ejection fraction;NYHA heart function class;Degree of mitral regurgitation;Incidence of adverse events;—

Countries

China

Contacts

Public ContactWang Chunsheng

Zhongshan Hospital

cswang@medmail.com.cn+86 13801978935

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026