MitralStitch Mitral Valve Repair System for Mitral Regurgitation
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|ClinicalTrials.gov Identifier: NCT04061837|
Recruitment Status : Enrolling by invitation
First Posted : August 20, 2019
Last Update Posted : August 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mitral Regurgitation||Device: MitralStitch||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||To Evaluate the Effectiveness and Safety of MitralStitch Mitral Valve Repair System - a Clinical Application of New Technology|
|Actual Study Start Date :||August 23, 2019|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||October 31, 2021|
Experimental: MitralStitch repair system
Experimental group is allocated to use novel mitral valve repair system manufactured by Hangzhou Valgen Medtech Co., Ltd
With transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial chordae or ege-to-ege repair using MitralStitch Mitral Valve Repair System
- 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.
- The success of device [ Time Frame: Immediately after repair ]The MitralStitch mitral valve repair system reaches the mitral valve and implant the chord and withdraw the system successfully.
- The success rate of operation [ Time Frame: Before discharge, an average of 7 days ]Mitral regurgitation was less than moderate before discharge.
- Incidence of major adverse events after device implantation [ Time Frame: 12months ]There were no major adverse events associated with device or operation within 12 months of device implantation.
- The classification of mitral regurgitation [ Time Frame: 1/6/12 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04061837
|Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University|
|Xi'an, Shaanxi, China, 710032|
|Principal Investigator:||Shiqiang Yu||Xijing Hospital|
|Study Director:||Jian Yang||Xijing Hospital|