SQ-Kyrin TMVr FIM Study

NCT05040074 | Recruiting

• 1 other identifier: VRP01-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A feasibility study to evaluate the effectiveness and safety of the SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System for the treatment of moderate-to-severe mitral regurgitation in patients with high surgical risk.

Conditions

Mitral Regurgitation

Keywords

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• Incidence of acute procedural success

  Must meet all the four items：1）no procedural mortality; 2）success in delivery and retrieval of the device delivery system; 3）successful deployment and accurate positioning of the device; 4）no emergency surgery or reintervention related to the device or surgical approach

  Immediate postoperative

Secondary Outcomes (4)

• All-cause mortality

  1 month

• Incidence of serious adverse event(SAE)

  1 month

• Device success rate

  1 month

• Procedural success rate

  1 month

Study Arms (1)

SQ-Kyrin TMVr Feasibility Study

EXPERIMENTAL

Experimental group is allocated to use the transcatheter edge-to-edge valve repair system of Shanghai Shenqi Medical Technology Co., Ltd.

Device: SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System

Interventions

SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System DEVICE

Transesophageal echocardiography-guided, implantable mitral valve clip repair system

SQ-Kyrin TMVr Feasibility Study

Eligibility Criteria

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

You may qualify if:

• Severe mitral valve regurgitation ≥ 3+ (moderate-to-severe mitral regurgitation disease);
• Patients with high or prohibitive risk for conventional open thoracic surgery as defined by STS risk scoring result; subjects who are judged as not tolerating mitral valve surgery due to STS procedural mortality risk ≥ 8% for mitral valve replacement or presence of any of the following risk factors:
• Porcelain aorta or active ascending aortic atheroma
• Prior radiation therapy to mediastinum
• History of mediastinitis
• Left ventricular ejection fraction (LVEF) \< 40%
• Presence of unobstructed coronary artery bypass graft
• History of 2 or more cardiothoracic surgeries
• Liver cirrhosis
• Other surgical risk factors
• Degenerated MR patients, or functional MR patients who have received guideline-directed medical therapy (GDMT therapy)
• Age ≥ 18 years, male or female;
• Patients who are at extremely high risk or not suitable for conventional mitral valve surgery, as assessed by a multidisciplinary heart team (including at least one cardiac surgeon and one cardiologist);
• Anatomically suitable for transcatheter mitral valve repair by edge-to-edge technique and can be treated by the SQ-Kyrin device;
• Patients who can understand the objectives of the trial, volunteer to participate in the study, sign the informed consent form, and are willing to receive related examinations and clinical follow-up.

You may not qualify if:

• History of cardiac and mitral valve surgeries;
• Infective endocarditis or evidence of active infection;
• Mitral valve stenosis;
• Severe uncontrolled coronary artery disease;
• Pulmonary artery hypertension (systolic pulmonary artery pressure \> 70 mmHg);
• Severe right cardiac insufficiency;
• LVEF \< 30%;
• Cardiac function of NYHA Class IV;
• Patient is extremely week to tolerate surgery under general anesthesia, or in a shock state indicating circulatory support;
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis;
• Chronic dialysis;
• Definite coagulation disorder and severe coagulation system diseases;
• Clear contraindications for use of anticoagulants;
• Cerebral stroke or transient ischemic attack in the past 30 days;
• Any cardiac mass, left ventricular or atrial thrombosis identified by echocardiography;

Sponsors & Collaborators

• Shanghai Shenqi Medical Technology Co., Ltd: lead

Study Sites (1)

General Hospital of Northern Theater Command, PLA

Shenyang, Liaoning, 123005, China

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Grace Gu

CONTACT

13636491192; guchaojun@sqmedical.com

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: August 12, 2021
• First Posted: September 10, 2021
• Study Start: April 1, 2021
• Primary Completion: October 1, 2022
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 10, 2021

Record last verified: 2021-08

Locations

CN (1)