Initial feasibility study for using novel transcatheter mitral valve repair system in treating patient with Severe mitral regurgitation - First in Man Study

Initial feasibility study for using novel transcatheter mitral valve repair system in treating patient with Severe mitral regurgitation -- First in Man Study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900021888

Enrollment

Unknown

Registered

2019-03-15

Start date

2018-02-01

Completion date

Unknown

Last updated

2019-03-18

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

Conditions

Mitral Valve regurgitation

Interventions

Case series:Transcatheter Mitral repair

Eligibility

Sex/Gender

Male

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Aged above 18 years Old; 2. MR degree =3+ (DMR); 3. STS Score =4% (Mitral repair model); 4. Patient sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Life life expectancy; 2. having coronary artery disease need intervention; 3. Myocardium infraction within 180 days; 4. have other cardiac disease need intervention; 5. LEVF55mm; 7. Mitral Annular diamater>45mm; 8. Mitral valve stenosis,calcification, leaflet shortening; 9. Functional MR; 10. Rheumatic heart disease; 11. Infective endocarditis; 12. Pulmonary hypertension; 13. Pregnant; 14. Dignosis with Cancer; 15. Apical access contraindication.

Design outcomes

Primary

Measure	Time frame
30 severe complication rate;	—

Secondary

Measure	Time frame
30 days Procedure success rate;	—

Countries

China

Contacts

Public ContactXiangbin Pan

Fuwai Hospital, National Center for Cardiovascular Diseases/Yunan Fuwai Hospital

xiangbin428@hotmail.com+86 13811763898

Outcome results

None listed

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