MitralStitch Mitral Valve Repair System for Mitral Regurgitation

Air Force Military Medical University of People's Liberation Army

Status

Unknown

Conditions

Mitral Regurgitation

Treatments

Device: MitralStitch

Study type

Interventional

Funder types

Other

Identifiers

NCT04061837

XJ-20190823

Details and patient eligibility

About

The main objective is to assess the effectiveness and safety of the MitralStitch repair system in patients with moderate to severe and severe mitral regurgitation.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The age of patient is ≥18yrs;
Severe mitral regurgitation patients (The area of central regurgitation exceeds 40% of left atrial area or holosystolic eccentric regurgitation; VC≥0.07cm；regurgitant volume ≥60ml；RF ≥50%; EROA≥0.4cm2 (Satisfy any condition).
LVESD≤60mm, LVEF≥25%, small incision surgery of chest can be tolerated.
The subject was informed of the clinical application nature of the new technology and agreed to participate in all requirements of the clinical application of the new technology, signed the ICF and agreed to complete the follow-up and the inspection required during the follow-up period.

Exclusion criteria

Subject who are pregnant, lactating or scheduled to pregnant during the period of the clinical new technology.
Subjects with active endocarditis or rheumatic mitral valve disease.
Life expectancy <1 year for cardiac or other malignant tumors.
Participate in other clinical trial
In the judgment of the investigator, subjects had poor acceptance of chemotherapy, and they cannot complete the trial as required.