Degenerated Mitral RegurgitationNCT06467110

Safety and Effectiveness Study of SQ-Kyrin TMVr System for Degenerated Mitral Regurgitation

A study testing transcatheter mitral valve clip delivery system and steerable guide catheter (Shenqi Medical) in people with Degenerated Mitral Regurgitation, run by Shanghai Shenqi Medical Technology Co., Ltd at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd.in patients with moderate-severe or severe degenerated mitral regurgitation (DMR). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Degenerated Mitral Regurgitation
What is being tested?: transcatheter mitral valve clip delivery system and steerable guide catheter (Shenqi Medical)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 118 participants
Where: 1 siteChina
Study dates: 15 Oct 2021to 15 Dec 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

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

Severe MR ≥3+ as determined by transthoracic echocardiography (TTE);
STS risk score results show that patients at high risk for traditional surgery or patients who cannot tolerate traditional thoracotomy: Subjects judged to be refractory to mitral valve surgery due to a ≥ 8% risk of death from STS surgery for surgical mitral valve replacement, or a ≥ 6% risk of death from STS surgery for surgical mitral valve repair, or because of any of the following risk factors:
Porcelain aorta or active ascending aortic plaque
Mediastinum treated with radiotherapy
Past mediastinitis
Left ventricular ejection fraction (LVEF) <40%

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Presence of a patent coronary bypass implant
Acceptance of two or more cardiothoracic surgeries
Liver cirrhosis
Other surgical risk factors
Patients with Degenerated MR (Degenerated MR);
Age ≥ 18 years old, regardless of gender;
Classification of cardiac function: NYHA class II, III or ambulatory class IV;
Patients assessed by a multidisciplinary cardiac team as very high-risk or unsuitable for routine mitral valve surgery;
Be able to understand the objective of the trial, and volunteered to participate and signed the Informed Consent Form, willing to accept the relevant examination and clinical follow-up.
Left ventricular end-systolic diameter (LVESD)≤60mm
The MR beam mainly originates from the A2/P2 area
Mitral valve disease prolapse lesion area width≤15mm, prolapse height≤10mm, effective length of anterior and posterior valve leaflets>10mm
Mitral valve effective orifice area (EOA) ≥ 4.0cm2
No obvious calcification of mitral valve leaflets
Patient anatomy allows atrial septum approach

Who cannot join

History of mitral valve surgery;
Patients with infective endocarditis or suggestive of active infection;
Complicated with severe untreated coronary artery disease;
Patients with pulmonary hypertension (pulmonary systolic blood pressure>70mmHg);
Patients with transthoracic echocardiographic evidence suggesting moderate-severe to severe right ventricular dysfunction;
Left ventricular ejection fraction <20%;

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Patients who are extremely frail and cannot tolerate general anesthesia surgery or is in the state of shock requiring circulatory support;
Patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis;
Mitral regurgitation due to active rheumatic heart disease or rheumatic etiology;
Severe renal insufficiency (eGFR ≤ 25 mL/min) or requiring chronic renal replacement therapy;
Patients with definite coagulation disorders and severe coagulation system diseases;
Patients with clear contraindications to the use of anticoagulants;
Patients with stroke or transient cerebral ischemic attack within 30 days;
Any intracardiac mass, left ventricular or atrial thrombus detected on transthoracic echocardiography;
Severe tricuspid TR;
Patients with other valve disease requiring surgery or interventional therapy;
Patients with severe macrovascular disease requiring surgical treatment;
Severe symptomatic carotid stenosis (>70% on ultrasonography) or carotid stenting within 30 days;
Patients with inappropriate anatomical structures of the heart and valves indicated by imaging examinations;
Known allergy to contrast agents and nickel-titanium memory alloy products;
R<testing systolic blood pressure 90 mmHg or >160 mmHg;
Patients with diseases that seriously affect the evaluation of treatment, such as patients with severe neurological lesions affecting cognitive ability, patients with malignant tumors, etc.;
Patient life expectancy < 12 months;
Patients with severe thoracic deformity;
Women who are pregnant, breastfeeding, or planning to become pregnant within the next 12 months.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

General Hospital of Northern Theater Command, PLA
Shenyang, Liaoning, 123005

Other trials in China

About this study

Official title: A Prospective, Multicenter, Single-Arm Clinical Trial to Assess the Safety and Efficacy of a Transcatheter Mitral Valve Clip Delivery System With Steerable Guide Catheter in Patients With Moderate-Severe or Severe Degenerative Mitral Regurgitation (DMR)

Read the detailed description

This study is clinical research using a prospective, multicenter, single arm method to evaluate the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter transcatheter mitral valve clip delivery system and steerable guide catheter in the treatment of patients with moderate-severe (3+) or severe (4+) degenerated mitral regurgitation. A total of 118 subjects are planned to be included in this trial. All subjects are treated with transcatheter mitral valve clip delivery system and steerable guide catheter transcatheter mitral valve clip delivery system and steerable guide catheter, and are followed up at 30 days, 6 months and 12 months after surgery. At the follow-up of 12 months after surgery, the composite endpoints of no death, no surgical mitral valve related surgery due to mitral valve dysfunction, and no moderate-severe or severe MR (MR > 2 +) are evaluated. After the follow-up of 12 months after surgery, the stage statistical analysis, clinical summary and application for product registration are performed.

Conditions: Degenerated Mitral Regurgitation
Being tested: transcatheter mitral valve clip delivery system and steerable guide catheter (Shenqi Medical)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

transcatheter mitral valve clip delivery system and steerable guide catheter (Shenqi Medical)Device
The principle of this product is the transcatheter interventional edge-to-edge repair technology (edge-to-edge repair). The core technology is to treat the regurgitation by edge-to-edge suturing the mitral valve. The double holes are set in the mitral valve (A2/P2 zone) or the edges in A1/P1 or A3/P3 zones are apposed and closed to treat regurgitation.

Study groups in NCT06467110
Study group	Role	What they receive
transcatheter mitral valve clip delivery system and steerable guide catheter (Shenqi Medical)	Experimental	The principle of this product is the transcatheter interventional edge-to-edge repair technology (edge-to-edge repair). The core technology is to treat the regurgitation by edge-to-edge suturing the mitral valve. The double holes are set in the mitral valve (A2/P2 zone) or the edges in A1/P1 or A3/P3 zones are apposed and closed to treat regurgitation. Receives: Device: transcatheter mitral valve clip delivery system and steerable guide catheter (Shenqi Medical)

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Incidence of composite endpoint of no death, no surgical mitral valve-related procedures due to mitral valve dysfunction, and no moderate-severe or severe MR (MR>2+) at 12 months after surgery
Incidence of composite endpoint of no death, no surgical mitral valve-related procedures due to mitral valve dysfunction, and no moderate-severe or severe MR (MR>2+) at 12 months after surgery
Measured: 12 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 202115 Dec 2028

First posted20 Jun 2024
Study start15 Oct 2021
Primary completion15 Dec 2024 (estimated)
Study completion15 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Degenerated Mitral RegurgitationStudies of the same condition, open and under way.
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: 118 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06467110
Sponsor's protocol ID: MVRP01-001B
Status last verified: Jul 2023
First submitted: 13 Jun 2024
Last updated: 20 Jun 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Xu K, Zhang J, Zhu D, Wang Y, Jiang H, Chen J, Chen J, Xiu J, He B, Zhang R, Guo X, Gao C, Zhong Z, Li P, Chai D, Jin J, Chen Y, Hong L, Tang Y, Fu G, Tao L, Yang Y, Zhou S, Liu B, Gan L, Yu B, Taramasso M, Pan X, Chen S, Han Y. Multicenter Evaluation of an Edge-to-Edge Repair System in High-Risk Patients With Degenerative Mitral Regurgitation. Struct Heart. 2026 Jan 6;10(5):100793. doi: 10.1016/j.shj.2026.100793. eCollection 2026 May.
PubMed 42078860

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruiting
Early Feasibility Study of NeoChord Transcatheter Mitral Repair System
Degenerative Mitral Regurgitation, Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse
Not yet recruiting
CardioFlow Transcatheter Mitral Valve Replacement System Pre-market Clinical Investigation
Degenerative Mitral Regurgitation
Recruiting
TVMR With the INNOVALVE System Trial - Early Feasibility Study
Mitral Valve Regurgitation (Degenerative or Functional)
Not yet recruiting
Anchord Mitral Chordal Repair System - FIH
Mitral Regurgitation
Recruiting
FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation
Degenerative Mitral Regurgitation

All Degenerated Mitral Regurgitation trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Single-Arm Clinical Trial to Assess the Safety and Efficacy of a Transcatheter Mitral Valve Clip Delivery System With Steerable Guide Catheter in Patients With Moderate-Severe or Severe Degenerative Mitral Regurgitation (DMR)
ClinicalTrials.gov ID: NCT06467110
Acronym / sponsor ID: MVRP01-001B
Conditions: Degenerated Mitral Regurgitation
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 118 participants (estimated)
Lead sponsor: Shanghai Shenqi Medical Technology Co., LtdIndustry (pharma, biotech, devices)
Study start: 15 Oct 2021 (actual)
Primary completion: 15 Dec 2024 (estimated)
Study completion: 15 Dec 2028 (estimated)
First posted: 20 Jun 2024 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
transcatheter mitral valve clip delivery system and steerable guide catheter (Shenqi Medical)	Experimental	Device: transcatheter mitral valve clip delivery system and steerable guide catheter (Shenqi Medical)The principle of this product is the transcatheter interventional edge-to-edge repair technology (edge-to-edge repair). The core technology is to treat the regurgitation by edge-to-edge suturing the mitral valve. The double holes are set in the mitral valve (A2/P2 zone) or the edges in A1/P1 or A3/P3 zones are apposed and closed to treat regurgitation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

Severe MR ≥3+ as determined by transthoracic echocardiography (TTE);
STS risk score results show that patients at high risk for traditional surgery or patients who cannot tolerate traditional thoracotomy: Subjects judged to be refractory to mitral valve surgery due to a ≥ 8% risk of death from STS surgery for surgical mitral valve replacement, or a ≥ 6% risk of death from STS surgery for surgical mitral valve repair, or because of any of the following risk factors:
Patients with Degenerated MR (Degenerated MR);
Age ≥ 18 years old, regardless of gender;
Classification of cardiac function: NYHA class II, III or ambulatory class IV;

Key exclusion criteria (25 listed)

History of mitral valve surgery;
Patients with infective endocarditis or suggestive of active infection;
Complicated with severe untreated coronary artery disease;
Patients with pulmonary hypertension (pulmonary systolic blood pressure>70mmHg);
Patients with transthoracic echocardiographic evidence suggesting moderate-severe to severe right ventricular dysfunction;

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
transcatheter mitral valve clip delivery system and steerable guide catheter (Shenqi Medical)The principle of this product is the transcatheter interventional edge-to-edge repair technology (edge-to-edge repair). The core technology is to treat the regurgitation by edge-to-edge suturing the mitral valve. The double holes are set in the mitral valve (A2/P2 zone) or the edges in A1/P1 or A3/P3 zones are apposed and closed to treat regurgitation.	Device	transcatheter mitral valve clip delivery system and steerable guide catheter (Shenqi Medical)

Primary outcome

1. Incidence of composite endpoint of no death, no surgical mitral valve-related procedures due to mitral valve dysfunction, and no moderate-severe or severe MR (MR>2+) at 12 months after surgery
Time frame: 12 months after surgery
Incidence of composite endpoint of no death, no surgical mitral valve-related procedures due to mitral valve dysfunction, and no moderate-severe or severe MR (MR>2+) at 12 months after surgery

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
Derived from this study: PubMed 42078860Xu K, Zhang J, Zhu D, Wang Y, Jiang H, Chen J, Chen J, Xiu J, He B, Zhang R, Guo X, Gao C, Zhong Z, Li P, Chai D, Jin J, Chen Y, Hong L, Tang Y, Fu G, Tao L, Yang Y, Zhou S, Liu B, Gan L, Yu B, Taramasso M, Pan X, Chen S, Han Y. Multicenter Evaluation of an Edge-to-Edge Repair System in High-Risk Patients With Degenerative Mitral Regurgitation. Struct Heart. 2026 Jan 6;10(5):100793. doi: 10.1016/j.shj.2026.100793. eCollection 2026 May.
Individual participant dataSharing planned: No

Related trials for Degenerated Mitral Regurgitation

Not yet recruiting
Early Feasibility Study of NeoChord Transcatheter Mitral Repair System
Degenerative Mitral Regurgitation, Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse
Not yet recruiting
CardioFlow Transcatheter Mitral Valve Replacement System Pre-market Clinical Investigation
Degenerative Mitral Regurgitation
Recruiting
TVMR With the INNOVALVE System Trial - Early Feasibility Study
Mitral Valve Regurgitation (Degenerative or Functional)
Not yet recruiting
Anchord Mitral Chordal Repair System - FIH
Mitral Regurgitation
Recruiting
FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation
Degenerative Mitral Regurgitation

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 21 inclusion and 25 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: enrolling by invitation, as of the sponsor's last update on 20 Jun 2024. 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?

This study is still under way. Results are not available in the source record yet.

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?

1. Incidence of composite endpoint of no death, no surgical mitral valve-related procedures due to mitral valve dysfunction, and no moderate-severe or severe MR (MR>2+) at 12 months after surgery (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06467110, which also lists 1 linked publication.

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 20 Jun 2024.