Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Официальное название

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR Transfemoral System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Обзор

Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.

Подробное описание

Prospective, single-arm, multi-center, interventional, pre-market trial

Вмешательства

• Устройство Medtronic Intrepid™ TMVR TF System
  Patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC will have a Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR Transfemoral System

Первичные конечные точки

• Safety: all-cause mortality at 1-year post-procedure. [Срок оценки: 1 year]
• Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure. [Срок оценки: 30 days]

Вторичные конечные точки (9)

• Rate of all-cause mortality (Safety). [Срок оценки: 30 days]
• Disabling stroke (Safety). [Срок оценки: 30 days]
• Acute Kidney Injury (stage 3 or with renal replacement) (Safety). [Срок оценки: 30 days]
• Reoperation or reintervention (Safety). [Срок оценки: 30 days]
• Major access site vascular complications (Safety). [Срок оценки: 30 days]
• Mitral valve regurgitation (Efficacy). [Срок оценки: 1 year]
• NYHA functional class (Efficacy). [Срок оценки: 1 year]
• Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) (Efficacy). [Срок оценки: 1 year]
• Cardiovascular hospitalizations (Efficacy). [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Subject has moderate-to-severe or severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines and Standards - Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation, or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of MAC
• Local site multidisciplinary heart team experienced in mitral valve therapies agrees that patient is unsuitable for treatment with approved transcatheter repair or conventional mitral valve surgery
• Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
• Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
• Subjects anatomically suitable for the Medtronic Intrepid™ TMVR TF System

Критерии исключения

• Estimated life expectancy of less than 24 months
• Currently surgically implanted mitral valve
• Prior transcatheter mitral valve procedure with device currently implanted
• Anatomic contraindications
• Anatomically prohibitive mitral annular calcification (MAC)
• Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment
• LVEF < 25% (measured by resting transthoracic echocardiogram), patients with LVEF 25 - <30% will be further evaluated by the Screening Committee for approval (Right Ventricular Dysfunction, pulmonary hypertension, and left ventricular function)
• Left ventricular end diastolic diameter (LVEDD) > 75mm
• Need for emergent or urgent surgery
• Hemodynamic instability
• History of bleeding diathesis or coagulopathy
• End stage renal disease
• Liver failure
• Frailty

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

Германия · 9 центров

• Heart and Diabetes Center NRW — Bad Oeynhausen
• Deutsches Herzzentrum der Charité (DHZC) — Berlin
• Universitätsklinikum Bonn — Bonn
• Universitäres Herz- und Gefäßzentrum Hamburg — Hamburg
• Herzzentrum Leipzig — Leipzig
• University Medical Center Mainz — Mainz
• Deutsches Herzzentrum München — München
• LMU Clinic of University Hospital München — München
• … и ещё 1 центр

Франция · 8 центров

• Clinique Pasteur — Toulouse
• CHU Bordeaux — Bordeaux
• Henri-Mondor University Hospital — Créteil
• CHU Timone — Marseille
• CHU de Nantes — Nantes
• CHU Rennes - Pontchaillou Hospital — Rennes
• Centre Cardiologique du Nord (CCN) — Saint-Denis
• CHRU de Tours — Tours

Италия · 5 центров

• Azienda Ospedaliero - Universitaria di Bologna - Policlinico S.Orsola Malpighi — Bologna
• Azienda Ospedaliera Spedali Civili di Brescia — Brescia
• Ospedale San Raffaele — Milan
• Azienda Ospedaliero Universitaria Pisana — Pisa
• IRCCS Policlinico San Donato — San Donato Milanese

Испания · 4 центра

• Hospital Clínic de Barcelona — Barcelona
• Hospital Universitario Ramón y Cajal — Madrid
• Central University Hospital of Asturias — Oviedo
• University Hospital Alvaro Cunqueiro — Vigo

Великобритания · 4 центра

• University Hospitals Sussex NHS Foundation Trust — Brighton
• Leeds General Infirmary — Leeds
• Guys & St Thomas NHS Foundation Trust - St Thomas Hospital London — London
• Royal Brompton Hospital — London

Дания · 3 центра

• Aarhus University Hospital — Aarhus
• Rigshospitalet — Copenhagen
• Odense University Hospital — Odense

Нидерланды · 3 центра

• Catharina Hospital — Eindhoven
• St. Antonius Hospital — Nieuwegein
• Erasmus University Medical Center — Rotterdam

Швейцария · 1 центр

• Universitätsspital Bern — Bern

Публикации

• Tang GHL, Rajagopal V, Sorajja P, Bajwa T, Gooley R, Walton A, Modine T, Ng MK, Williams MR, Zajarias A, Hildick-Smith D, Tchetche D, Spargias K, Rajani R, Bapat VN, De Backer O, Blackman D, McCarthy P, Laine M, Jain R, Martin R, Thaden JJ, Marka NA, Mack M, Adams DH, Leon MB, Reardon MJ. Five-year outcomes of the early-generation Intrepid transapical transcatheter mitral valve replacement system. PMID 41251714

Идентификаторы

NCT: NCT05496998 · MDT22008TMV005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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