MitralStitch Mitral Valve Repair System for Mitral Regurgitation

Xijing Hospital10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mitral Regurgitation

Interventions

MitralStitchDEVICE

With transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial chordae or ege-to-ege repair using MitralStitch Mitral Valve Repair System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The age of patient is ≥18yrs; 2. 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). 3. LVESD≤60mm, LVEF≥25%, small incision surgery of chest can be tolerated. 4. 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: 1. Subject who are pregnant, lactating or scheduled to pregnant during the period of the clinical new technology. 2. Subjects with active endocarditis or rheumatic mitral valve disease. 3. Life expectancy \<1 year for cardiac or other malignant tumors. 4. Participate in other clinical trial 5. In the judgment of the investigator, subjects had poor acceptance of chemotherapy, and they cannot complete the trial as required.

Locations (1)

Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Outcomes

Primary Outcomes

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

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.

Time frame: 30days

Secondary Outcomes

The success of device

The MitralStitch mitral valve repair system reaches the mitral valve and implant the chord and withdraw the system successfully.

Time frame: Immediately after repair

The success rate of operation

Mitral regurgitation was less than moderate before discharge.

Time frame: Before discharge, an average of 7 days

Incidence of major adverse events after device implantation

There were no major adverse events associated with device or operation within 12 months of device implantation.

Time frame: 12months

The classification of mitral regurgitation

Mild: No mitral regurgitation or the centricity regurgitation area is smaller than the 20% of left atrial area. Moderate: The area of centricity regurgitation is upper than 40%, lower than 60% of the left atrial area; VC≥0.7cm; regurgitant volume≥60ml； RF≥50%; EROA≥0.4cm². Severe: The area of centricity regurgitation is upper than 40% of the left atrial area or systolic eccentric regurgitation.

Time frame: 1/6/12 months

Data from ClinicalTrials.gov

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