Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk

Обзор

to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.

Вмешательства

• Устройство HighLife Transcatheter Mitral Valve Replacement
  Transcatheter Mitral Valve Replacement

Первичные конечные точки

• Device Safety [Срок оценки: 30 days]

Критерии участия

Критерии включения

• 1\. Age ≥ 18 years 2. Moderate-severe or severe mitral regurgitation (≥ 3+) 3. Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV 4. Patient is under guideline directed medical therapy, as reviewed and confirmed by the local multidisciplinary Heart Team, for at least one month 5. Patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty, and disability 6. Patient meets the anatomical criteria for HighLife valve 7. Patient is willing to participate in the study and provides signed informed consent

Критерии исключения

• Any stroke/TIA within 30 days
• Severe symptomatic carotid stenosis (> 70% by non-invasive imaging)
• Active infections requiring antibiotic therapy
• Active ulcer or gastro-intestinal bleeding in the past 3 months
• History of bleeding diathesis, coagulopathy or refusal of future blood transfusion
• Patients in whom TEE is not feasible
• Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.
• Patient is unable to comply with the follow-up schedule and assessments
• Participation in another clinical investigation at the time of inclusion
• Patient has known allergies to the device components or contrast medium
• Patient cannot tolerate anticoagulation or antiplatelet therapy
• Patients with a life expectancy of less than 12 months due to non-cardiac conditions
• Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months

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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

Франция · 12 центров

• Rangueil University Hospital — Toulouse
• CHU Lille — Lille
• Medipole Lyon-Villeurbanne — Lyon
• Hopital Prive - Jacques Cartier — Massy
• Centre Hospitalo-Universitaire de Nantes — Nantes
• European Hospital George Pompidou — Paris
• CHU Bordeaux — Pessac
• CHU de Rennes — Rennes
• … и ещё 4 центра

Австралия · 11 центров

• St. Vincent's Hospital - Sydney — Darlinghurst
• John Hunter Hospital — Newcastle
• Macquarie University Hospital — Sydney
• The Wesley Hospital — Auchenflower
• St. Andrew's Hospital — Adelaide
• Princess Alexandra Hospital — Brisbane
• Warringal Hospital — Heidelberg
• The Alfred Hospital — Melbourne
• … и ещё 3 центра

Германия · 10 центров

• University Heart Center Freiburg - Bad Krozingen — Bad Krozingen
• Universitaetsklinikum Bonn — Bonn
• Heart Center, University Hospital Dresden — Dresden
• Universitatsklink Hamburg-Eppendorf — Hamburg
• Mediinisches Versorgungszentrum — Hamburg
• University Hospital Heidelberg — Heidelberg
• Herzentrum Leipzig — Leipzig
• Deutsches Herzzentrum Munchen — Munich
• … и ещё 2 центра

Великобритания · 8 центров

• Royal Victoria Hospital — Belfast
• Brighton and Sussex University Hospital — Brighton
• Royal Infirmary of Edinburgh — Edinburgh
• Leeds Teaching Hospitals NHS Trust — Leeds
• University Hospitals of Leicester NHS Trust — Leicester
• Guy's and St. Thomas' NHS Foundation Trust - St. Thomas Hospital — London
• Barts Heart Center — London
• John Radcliffe — Oxford

Польша · 5 центров

• Medical University of Gdansk — Gdansk
• Medical University of Silesia Hospital — Katowice
• University Hospital of Lord's Transfiguration — Poznan
• Medical University of Warsaw — Warsaw
• Institute of Cardiology — Warsaw

Бельгия · 3 центра

• ZNA Middelheim — Antwerp
• AZ Sint-Jan — Bruges
• UZ Leuven — Leuven

Сингапур · 1 центр

• National Heart Center Singapore — Singapore

Публикации

• Schneider LM, Worthley S, Nickenig G, Huczek Z, Wojakowski W, Tchetche D, Dubois C, Nasr M, Verhees L, Rothman M, Piazza N, Buithieu J, Yeow WL, Kessler M, Rottbauer W. 1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: The HighLife TSMVR Feasibility Study. JACC Cardiovasc Interv. 2023 Dec 11;16(23):2854-2865. doi: 10.1016/j.jcin.2023.09.003. Epub 2023 Nov 2 PMID 37999708

Идентификаторы

NCT: NCT04029363 · HL-2018-01-TS Expanded EU/AU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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