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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
Sponsor:
Information provided by (Responsible Party):
Jian Yang, Xijing Hospital

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.

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Device: MitralStitch Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: MitralStitch repair system
Experimental group is allocated to use novel mitral valve repair system manufactured by Hangzhou Valgen Medtech Co., Ltd
Device: MitralStitch
With transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial chordae or ege-to-ege repair using MitralStitch Mitral Valve Repair System




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. The success rate of operation [ Time Frame: Before discharge, an average of 7 days ]
    Mitral regurgitation was less than moderate before discharge.

  3. 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.

  4. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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China, Shaanxi
Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
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Principal Investigator: Shiqiang Yu Xijing Hospital
Study Director: Jian Yang Xijing Hospital

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Responsible Party: Jian Yang, Deputy chief surgeon, Xijing Hospital
ClinicalTrials.gov Identifier: NCT04061837     History of Changes
Other Study ID Numbers: XJ-20190823
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases