Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation

NCT05655897 | Recruiting

• 1 other identifier: 22CSP001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

To observe and evaluate the safety and efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation through a prospective, multicenter clinical trial using objective performance criteria.

Conditions

Mitral Regurgitation; Degenerative Mitral Valve Disease

Outcome Measures

Primary Outcomes (1)

• Treatment success

  Percentage of patients freedom from: death, surgery for valve dysfunction, and MR \> 2+ (moderate to severe (3+) or severe (4+) mitral regurgitation) .

  12 months

Secondary Outcomes (5)

• Acute procedural success

  Immediately after procedure, Discharge: 1 day after the patient's exit from the cardiac catheterization laboratory

• Acute device success

  Immediately after procedure

• Composite of function and re-operation measures

  30 days, 6 months, and 12 months

• Cardiac function change

  30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years

• Quality of life improvement

  12 months

Other Outcomes (3)

• Incidence of major adverse events (MAEs)

  30 days, 6 months, and 12 months

• All-cause mortality

  30 days, 6 months, and 12 months

• Cardiac mortality

  30 days, 6 months, and 12 months

Study Arms (1)

A single set of test

EXPERIMENTAL

The GeminiOne Transcatheter Valve Edge-to-Edge Repair System consists of a transcatheter valve clamping system and an adjustable curved introducer catheter.

Device: GeminiOne Transcatheter Valve Edge-to-Edge Repair System

Interventions

GeminiOne Transcatheter Valve Edge-to-Edge Repair System DEVICE

The transcatheter valve clamp system consists of a valve clamp, an adjustable bend mid-tube, and a manipulated inner tube. The adjustable bend introducer catheter consists of an adjustable bend outer tube and dilator. The valve clip is composed of nickel-titanium alloy, cobalt-chromium-nickel-molybdenum-iron alloy, and polyethylene terephthalate material and contains a closure clip, gripping tab, central mechanism, braid, and suture. The adjustable bend guiding catheter is used to provide access to the transcatheter valve clamping system and to reach the designated position. The adjustable curved mid-tube and manipulated inner tube are used to enable the delivery, gripping, and release process of the valve clips within the body.

A single set of test

Eligibility Criteria

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

You may qualify if:

• Patients who volunteer to participate and sign an informed consent form, understand the purpose of the clinical trial and are able to cooperate throughout the trial process;
• An age ≥ 18 years;
• Diagnostic transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days to determine the presence of symptomatic moderate-severe or severe degenerative mitral regurgitation (defined as mitral regurgitation grade ≥3+);
• Patients' New York Heart Association (NYHA) cardiac function classification (see Appendix II) in grades II, III, or non-ambulatory grade IV；
• Patients' left ventricular ejection fraction LVEF ≥ 20%;
• Patients considered to be at high surgical risk by the multidisciplinary cardiac team ;
• Patients are anatomically suitable for mitral valve repair and suitable for the device under this study as assessed by the multidisciplinary cardiac team;
• Elements include, however, are not constrained to the following:
• Mitral valve orifice area ≥ 4.0 cm2;
• Left ventricular end-systolic dimension (LVESD) ≤ 60 mm;
• The primary regurgitant bundle is a non-conjunctive regurgitant bundle and if the secondary regurgitant bundle is present, must be clinically insignificant;
• Transeptal puncture and femoral venipuncture are feasible; The recommended reference criteria for high surgical risk are: an STS score of ≥8 for surgical valve replacement (see Appendix III) or an STS score of ≥6 for surgical valve repair, or the existence of other high-risk factors, such as the presence of other high-risk elements such as the presence of ≥ 2 warning signs of moderate-severe frailty or the presence of feasible surgical operative limitations or the presence of ≥ 2 main organs dysfunctions that cannot be elevated postoperatively or other surgical high-risk factors that are genuinely existing in the judgment of the independent cardiac surgeon in this study.

You may not qualify if:

• The presence of intra-cardiac space occupancy, thrombus, or bulky organisms as indicated by echocardiography;
• The presence of other severe heart valve diseases requiring surgical intervention;
• Leaflet anatomy that may prevent implantation of the valve clip, proper positioning on the leaflet, or prevent adequate reduction of mitral regurgitation by the valve clip. The assessment is based on transesophageal echocardiographic (TEE) mitral valve evaluation within 180 days prior to the subject's registration and includes:
• inability of the valve clips to hold sufficient active leaflets;
• lack of primary and secondary tendon support in the clamping area;
• significant evidence of calcification in the clamping area;
• significant fissures in the clamping area;
• Active endocarditis, pericarditis, or rheumatic heart disease; or mitral valve leaflet changes resulting from endocarditis or rheumatic heart disease;
• Severe right ventricular insufficiency (e.g. with symptoms of bilateral lower limb edema with increased jugular venous pressure and hepatomegaly); or pulmonary hypertension (pulmonary artery systolic pressure PASA \> 70 mmHg as measured by echocardiography);
• Patients who have had an acute coronary syndrome within 4 weeks, or untreated severe coronary artery stenosis requiring revascularization;
• Patients with any cardiovascular intervention, cardiac surgery, cardiac resynchronization therapy (CRT, CRT-D), implantation of a buried cardioverter-defibrillator (ICD), etc. within 30 days; or have planned one of these procedures;
• Patients underwent mitral valve surgery or mitral transcatheter valve surgery before, or have a left atrial appendage occluder device inside；
• Patients with end-stage heart failure (ACC/AHA stage D), or after cardiac transplantation, or awaiting cardiac transplantation;
• Patients who are hemodynamically unstable, defined as systolic blood pressure \<90 mmHg without postload-reducing drugs, or in cardiogenic shock; or are requiring intra-aortic balloon counterpulsation, or other hemodynamic support drugs or devices;
• Patients requiring emergency or urgent surgery for any reason;

Sponsors & Collaborators

• Peijia Medical Technology (Suzhou) Co., Ltd.: lead

Study Sites (1)

Peiga Medical Technology (Suzhou) Co.

Suzhou, Jiangsu, 215025, China

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Jinjin Zhang

CONTACT

+86-13814870113; jameszhang@peijiamedical.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: November 30, 2022
• First Posted: December 19, 2022
• Study Start: November 24, 2022
• Primary Completion: November 24, 2025
• Study Completion (Estimated): November 24, 2029
• Last Updated: June 5, 2024

Record last verified: 2024-06

Locations

CN (1)