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Comparison of the curative effect of different mitral valvuloplasty on mitral regurgitation

A randomized controlled study of total thoracoscopic mitral valvuloplasty for lobectomy and leaflet retention for mitral regurgitation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057680
Enrollment
Unknown
Registered
2022-03-15
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

Heart valve disease

Interventions

observation group:Complete preservation of mitral valve leaflets
control group:mitral valve leaflet resection

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Age = 18 years old, gender is not limited; 2.A clear diagnosis of primary mitral regurgitation was made by cardiac ultrasound, electrocardiogram and other related examinations: (2014 AHA/ACC guidelines: moderate or above regurgitation, or regurgitation flow per beat = 30ml, or reverse Flow fraction = 30%, or regurgitation port area = 0.2 cm2, when multiple indicators are inconsistent, the more serious one shall prevail); 3.Evaluation of the mitral valve after intraoperative cardiac arrest and left atrial incision to verify that both leaflet resection and leaflet preservation strategies are feasible; 4.The patient himself agrees to participate in this clinical study and signs the informed consent.

Exclusion criteria

Exclusion criteria: 1. Aortic valve surgery is planned at the same time; 2. Significant left ventricular dysfunction (LVEF<40%); 3. Moderate aortic regurgitation, severe mitral valve annular calcification; 4. Spinal deformity, thoracic deformity, severe thoracic adhesion; 5. Taking other experimental drugs or participating in other clinical studies within 1 month before being enrolled in the study; 6. The researcher believes that it is not suitable to participate in this clinical researcher.

Design outcomes

Primary

MeasureTime frame
mitral valve opening area;Mitral valve mean transvalvular gradient;Mitral valve gradient at peak motion and at rest;

Secondary

MeasureTime frame
6 minutes walking distance;

Countries

China

Contacts

Public ContactZhou Yang

Leshan People's Hospital

506225182@qq.com+86 13990905276

Outcome results

None listed

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