MitralStitch Mitral Valve Repair System for Mitral Regurgitation

Mitral Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04061837
• Other study ID #: XJ-20190823
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 23, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: August 2019
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

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

Locations

Country	Name	City	State
China	Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30days
Secondary	The success of device	The MitralStitch mitral valve repair system reaches the mitral valve and implant the chord and withdraw the system successfully.	Immediately after repair
Secondary	The success rate of operation	Mitral regurgitation was less than moderate before discharge.	Before discharge, an average of 7 days
Secondary	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.	12months
Secondary	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.	1/6/12 months