Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)

Обзор

The purpose of this study is to evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.

Подробное описание

Prospective, single-arm, single-center clinical evaluation of transcatheter mitral valve intervention in subjects with mitral valve disease who are treated per standard of care and who have been determined by the local heart team as appropriate for interventional treatment. Eligible subjects will be treated by transcatheter mitral valve repair or transcatheter mitral valve replacement.

This single-arm registry will provide valuable new information regarding use of multiple mitral valve interventional devices and evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.

Вмешательства

• Устройство transcatheter mitral valve repair/transcatheter mitral valve replacement
  transcatheter mitral valve repair/transcatheter mitral valve replacement

Первичные конечные точки

• Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure. [Срок оценки: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years]

Вторичные конечные точки (12)

• All-cause mortality [Срок оценки: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years]
• Cardiovascular mortality [Срок оценки: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years]
• Rehospitalization related to heart failure [Срок оценки: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years]
• Stroke [Срок оценки: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years]
• Transient ischemic attack [Срок оценки: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years]
• Brain lesion [Срок оценки: Predischarge]
• Myocardial infarction [Срок оценки: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years]
• Vascular complications [Срок оценки: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years]
• Bleeding events [Срок оценки: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years]
• Permanent pacemaker implantation [Срок оценки: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years]
• Device success [Срок оценки: Immediately after procedure]
• Infective endocarditis [Срок оценки: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years]

Критерии участия

Критерии включения

• Patients with mitral valve disease, as determined by the site from a transthoracic echocardiogram (TTE), and in the judgment of the investigator intervention is likely to provide clinical benefit for the patient.
• Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
• The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
• Patients are technical and anatomical eligible for interventions.

Критерии исключения

• In the judgment of the investigator, subjects are not anatomical eligible for interventions.
• Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
• Active endocarditis or active rheumatic heart disease.
• History of severe bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
• Subject has any kind of conditions that might prevent patients benefiting from therapeutic benefit (i.e., Severe mental illness) or life expectancy is less than one year.
• Subject has any kind of disorder per investigator's judgement that compromises his/her ability to give written informed consent and/or to comply with study procedures.

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

Китай · 1 центр

• The Second Affiliated Hospital Zhejiang University School of Medicine. — Ханчжоу

Публикации

• Pu Z, Yu T, Liu X, Lin X, Li H, Lim DS, Wang J. A modified Carpentier classification in transcatheter edge-to-edge repair for mitral regurgitation. Catheter Cardiovasc Interv. 2024 Oct;104(4):870-877. doi: 10.1002/ccd.31158. Epub 2024 Jul 24. PMID 39049480

Идентификаторы

NCT: NCT04954404 · 2021-0593

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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