To Evaluate the Effectiveness and Safety of MitralStitch Mitral Valve Repair System - a Clinical Application of New Technology

Xijing Hospital1 site in 1 country10 target enrollmentAugust 23, 2019

ConditionsMitral Regurgitation

Overview

Phase: N/A
Intervention: Not specified
Conditions: Mitral Regurgitation
Sponsor: Xijing Hospital
Enrollment: 10
Locations: 1
Primary Endpoint: The occurrence rate of major adverse event after 30 days of the intervention
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 23, 2019

End Date

October 31, 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Xijing Hospital

Responsible Party

Principal Investigator

Jian Yang

Deputy chief surgeon

Xijing Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The occurrence rate of major adverse event after 30 days of the intervention

Time Frame: 30days

The occurrence of complications associated with any device or operation, including but not limited to: death, emergency surgery, severe pericardial tamponade requiring pericardiac puncture or surgery, bleeding, and surgically related stroke.