Mitral RegurgitationNCT04061837
MitralStitch Mitral Valve Repair System for Mitral Regurgitation
A study testing MitralStitch in people with Mitral Regurgitation, run by Xijing Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- MitralStitch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2019to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: To Evaluate the Effectiveness and Safety of MitralStitch Mitral Valve Repair System - a Clinical Application of New Technology
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.
- Conditions
- Mitral Regurgitation
- Being tested
- MitralStitch
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitralStitchDevice
With transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial chordae or ege-to-ege repair using MitralStitch Mitral Valve Repair System
| Study group | Role | What they receive |
|---|---|---|
| MitralStitch repair system | Experimental | Experimental group is allocated to use novel mitral valve repair system manufactured by Hangzhou Valgen Medtech Co., Ltd Receives: Device: MitralStitch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30days
Secondary outcomes (4)
The success of device
The MitralStitch mitral valve repair system reaches the mitral valve and implant the chord and withdraw the system successfully.
Measured: Immediately after repair
The success rate of operation
Mitral regurgitation was less than moderate before discharge.
Measured: 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.
Measured: 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.
Measured: 1/6/12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start23 Aug 2019
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Yang, Xijing Hospital
- Investigators
- Shiqiang Yu, Principal investigator, Xijing HospitalJian Yang, Study director, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061837
- Sponsor's protocol ID
- XJ-20190823
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Effectiveness and Safety of MitralStitch Mitral Valve Repair System - a Clinical Application of New Technology
- ClinicalTrials.gov ID
- NCT04061837
- Acronym / sponsor ID
- XJ-20190823
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MitralStitch repair system | Experimental | Device: MitralStitchExperimental group is allocated to use novel mitral valve repair system manufactured by Hangzhou Valgen Medtech Co., Ltd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitralStitchWith transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial chordae or ege-to-ege repair using MitralStitch Mitral Valve Repair System | Device | MitralStitch repair system |
Primary outcome
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.
4 secondary outcomes
The success of device
Time frame: Immediately after repair
The success rate of operation
Time frame: Before discharge, an average of 7 days
Incidence of major adverse events after device implantation
Time frame: 12months
The classification of mitral regurgitation
Time frame: 1/6/12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiqiang Yu principal investigator
Xijing Hospital
Jian Yang study director
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MitralStitch in people with Mitral Regurgitation, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence rate of major adverse event after 30 days of the intervention (time frame: 30days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.