EXPLORE FMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation

Официальное название

Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation (EXPLORE FMR)

Обзор

An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe functional mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. The study will enroll up to 10 patients at one (1) center in Brazil.

Подробное описание

Percutaneous approaches to treat MR promise to provide a sufficient reduction in MR without the risks typically associated with open heart surgery.

Furthermore there is an unmet clinical need for patients with severe MR who are refused or denied surgery due to high risk. Percutaneous therapy provides a novel alternative treatment option for these patients with the aim of reducing morbidity and mortality over and above current medical therapy. The Polares Medical PLAR Implant and Delivery System is a catheter-based technology designed to permanently implant a prosthesis using a transvenous / transseptal approach to augment the posterior mitral valve leaflet and improve coaptation with the anterior leaflet. Approved edge-to-edge repair has already been shown to be a viable alternative for high risk MR patients. However treatment with these devices is limited to specific anatomies and often requires multiple devices which increases clinical risk, adds to procedural time, and can result in residual MR. The PLAR Implant and Delivery System has been designed to overcome and mitigate some of these shortfalls.

Вмешательства

• Устройство Transcatheter mitral valve repair (PLAR Implant and Delivery System)
  The PLAR Implant is placed on the mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture

Первичные конечные точки

• Incidence of all-cause mortality [Срок оценки: 30-days follow-up]
• Incidence of change from baseline to moderate or less mitral regurgitation (Grade 2+ or less) as evaluated by 2D TTE Primary performance endpoint [Срок оценки: 30-days follow-up]

Вторичные конечные точки (5)

• Rate of major safety events as defined by MVARC2 definitions [Срок оценки: Follow-up at 30 days, at 6 and 12 months, and at 2, 3, 4 and 5 years]
• Technical success rate per MVARC2 definitions [Срок оценки: Technical success is measured immediately following the procedure]
• Procedure success rate per MVARC2 definitions [Срок оценки: Procedure success is measured at 30 days follow-up]
• Device success rate per MVARC 2 definitions [Срок оценки: Device success is measured at 30 days, at 6 and 12 months, and at 2, 3, 4, and 5 years follow-up]
• Patient success rate per MVARC2 definitions [Срок оценки: Patient success is measured at 12 months follow-up]

Критерии участия

Критерии включения

• 18 years of age or older
• Greater than moderate functional mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
• Patient must present with an STS Score less than 10%
• High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications), but operable, as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
• New York Heart Association (NYHA) Functional Class III or IV
• Patient willing to participate in study and provide signed IRB/EC-approved informed consent
• Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits

Критерии исключения

• Severe tricuspid regurgitation
• Severe aortic stenosis or insufficiency
• Severe mitral annulus calcification
• Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification
• Implanted vena cava filter
• Femoral veins with severe angulation and calcification
• Contraindication for transesophageal echocardiography (TEE) or MDCT scan
• Active infection or endocarditis
• Previous mitral valve surgery
• Prior orthotopic heart transplantation
• Pulmonary artery systolic hypertension > 70mmHg
• Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus
• Left ventricular ejection fraction (LVEF) < 30%
• Implant or revision of any pacing device < 30 days prior to intervention
• Symptomatic coronary artery disease treated < 30 days prior to study procedure
• Myocardial infarction requiring intervention < 30 days prior to study procedure
• Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis
• Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to study procedure
• Stroke < 180 days prior to study procedure
• Severe renal insufficiency (creatinine > 3.0 mg/dL) or patient requiring dialysis
• Cardiogenic shock at time of enrolment
• Hemodynamic instability requiring inotropic support or mechanical heart assistance
• Concurrent medical condition with a life expectancy of less than 2 years
• Pregnancy at time of enrolment
• History of bleeding diathesis or coagulopathy or leukopenia (WBC < 3,000 mcL) or acute anemia (Hb < 9 g/dL) or thrombocytopenia (platelets < 50,000 cells mcL)
• Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated
• Severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial/procedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments
• Emergency situations
• Company employees or their immediate family members
• Patient is under guardianship
• Patient is participating in another clinical study for which follow-up is currently ongoing

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

Оценка устройства

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT04679714 · 202004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗