A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.

Официальное название

A Clinical Study of GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System for the Treatment of Severe, Symptomatic Mitral Regurgitation (MR).

Обзор

To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.

Подробное описание

This study is a prospective, multi-center, non-randomized clinical trial. All enrolled subjects will receive the investigational GeminiOne TEER System in a single-arm design. The trial will be conducted at up to seven clinical centers located in the United States, Canada, and Europe.

The GeminiOne TEER System is intended for use in adult patients with severe symptomatic mitral regurgitation (MR) who have suitable anatomy for both device implantation and transfemoral trans-septal access for left atrial delivery.

Key Inclusion Criteria:

Primary MR: Patients must be deemed high-risk for surgical intervention by the site's heart team.

Secondary MR: Patients must have failed to respond to optimal guideline-directed medical therapy (GDMT) for at least one month, and must also have received appropriate coronary revascularization and cardiac resynchronization therapy (CRT), if indicated.

Initially, up to 15 subjects will be treated. The total duration of the study is expected to be approximately 72 months. The enrollment period will span approximately 12 months. Subjects who receive the investigational device will be followed for 60 months post-implantation.

Вмешательства

• Устройство GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System
  The GeminiOne TEER System consists of a TEER clip implant, transcatheter delivery system and a guide sheath. The clip is made of cobalt-chromium-nickel alloy with a nickel-titanium alloy gripper, covered with a braided mesh of polyethylene terephthalate (PET) materials.

Первичные конечные точки

• Safety: Absence of device or procedure related major adverse events at 30 days [Срок оценки: 30 days]
• Effectiveness: Acute procedural success (APS) [Срок оценки: 30 days]

Вторичные конечные точки (9)

• All-cause mortality and stroke [Срок оценки: 30 days, 12 months and annually thereafter]
• Cardiovascular mortality [Срок оценки: 30 days, 12 months and annually thereafter]
• Rate of cardiovascular rehospitalization [Срок оценки: 30 days, 12 months and annually thereafter]
• Mitral valve surgery or re-intervention [Срок оценки: 30 days, 12 months and annually thereafter]
• Change in NYHA functional class [Срок оценки: 30 days, 12 months and annually thereafter]
• Mitral valve hemodynamics [Срок оценки: 30 days, 12 months and annually thereafter]
• Change in 6-Minute Walk Test (6MWT) performance [Срок оценки: 30 days, 12 months and annually thereafter]
• Change in Quality of Life as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) [Срок оценки: 30 days, 12 months and annually thereafter]
• Incidence of serious adverse events (SAEs) [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Age 18 years or older(≥ 18 years)
• Subject has severe MR (Grade lll or greater per the ASE criteria, which includes severity grades of 3+ and 4+). Severity grades (3+)/ (4+) MR confirmed by core lab review on transthoracic or transesophageal echocardiography.

For patients with primary mitral regurgitation: Deemed high or prohibitive surgical risk (STS score 8 for valve replacement or > 6 for valve repair or determined by the site heart team due to documented surgical risk factors) For patients with secondary mitral regurgitation: undergone optimal guideline-directed medical therapy (GDMT) for at least one month as determined by the local heart team; coronary revascularization, and cardiac resynchronization therapy (CRT) if clinically indicated, all of which have proven to be ineffective. Local heart team has determined that mitral valve surgery is not an option.

• Anatomically suitable for TEER with GeminiOne device as confirmed by site investigators, core lab, and eligibility committee.
• Feasible transseptal catheterization and femoral vein access.
• Written informed consent from subject or legal representative.

Критерии исключения

• History of heart transplantation, prior mitral valve replacement surgery, or transcatheter mitral valve procedure.
• Leaflet anatomy that precludes optimal positioning of the GeminiOne device, as determined by site investigators, core lab, and eligibility committee.
• Evidence of severe calcification or significant cleft in the grasping area of the mitral valve leaflets.
• Left ventricular ejection fraction (LVEF)< 20%
• Left ventricular end-systolic diameter(LVESD)> 60mm
• Mobile leaflet length less than 10mm
• Mitral valve effective orifice area (EOA) < 3.5cm or a high risk of mitral stenosis developing after device implantation, as judged by site investigators, core lab, and eligibility committee.
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
• Presence of severe non-mitral valve disease requiring intervention.
• Severe pulmonary artery hypertension(sPAP >70mmHg).
• Severe right ventricular dysfunction. 12, Active endocarditis or history of mitral valve endocarditis. Active rheumatic heart disease or leaflets severely degenerated from rheumatic disease.

13\. Severe untreated coronary artery stenosis requiring revascularization or other cardiovascular disease requiring surgery.

14.Patents with extreme frailty. 15.Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure besides dilated cardiomyopathy.

16\. Severe renal insufficiency with estimated glomerular filtration rate (eGFR) < 25 mL/min.

17\. Blood cachexia including granulocytopenia(WBC<3x10\^9/L),acute anemia(HB <90g/L)thrombocytopenia (PLT <50x10\^9/L), severe coagulopathy, or contraindications to anticoagulant and antiplatelet therapy.

18\. Evidence of an acute myocardial infarction within the past 4 weeks. 19.Evidence of stroke within the prior 90 days. 20. Any percutaneous cardiac intervention, carotid surgery, or any cardiac surgery within 30 days prior to procedure.

21\. Severe symptomatic carotid artery stenosis exceeding 70% confirmed by imaging.

22\. Subjects with underlying medical or psychiatric conditions that may interfere with trial evaluation (e.g. cancer, infection, severe metabolic disease). Additionally, any case deemed unsuitable for the study by the local heart team.

23.Life expectancy of less than 12 months. 24. Participation in another investigational drug or device study within the past 1 month.

25\. Subjects deemed unlikely to complete the trial due to potential non-compliance, as judged by the investigator.

26\. Any anatomic characteristic or presence of atrial septal occluders, which would preclude the performance of the transseptal approach.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Los Robles Regional Medical Centre — Thousand Oaks

Идентификаторы

NCT: NCT07086534 · EFSGemini1US

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗