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

NCT06467110 | Enrolling By Invitation

• 1 other identifier: MVRP01-001B
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Degenerated Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• 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

  12 months after surgery

Study Arms (1)

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.

Device: transcatheter mitral valve clip delivery system and steerable guide catheter (Shenqi Medical)

Interventions

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.

transcatheter mitral valve clip delivery system and steerable guide catheter (Shenqi Medical)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• 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.

You may not qualify if:

• 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%;
• 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;

Sponsors & Collaborators

• Shanghai Shenqi Medical Technology Co., Ltd: lead

Study Sites (1)

General Hospital of Northern Theater Command, PLA

Shenyang, Liaoning, 123005, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 20, 2024
• Study Start: October 15, 2021
• Primary Completion: December 15, 2024
• Study Completion (Estimated): December 15, 2028
• Last Updated: June 20, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)