Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China

Обзор

The purpose of this study was to observe the safety and effectiveness of transcatheter aortic valve replacement in patients with aortic valve stenosis in a real-world clinical practice environment.

Подробное описание

This study is a prospective / retrospective, multicenterstudy after listing. The researchers preliminarily confirmed that they could be enrolled in this study according to the diagnosis of the subjects' medical history. After fully informed, they signed the informed consent, and met the TAVR inclusion requirements (see the inclusion criteria for details). At the same time, they registered the subjects in multiple centers. After the start of the trial, the participants were enrolled in the study, All the subjects who met the inclusion criteria but did not meet the discharge criteria were registered in the central registration system. The patients were followed up for 30 days, 6 months and 12 months, and followed up by telephone for 2, 3, 4 and 5 years.

Вмешательства

• Другое All aortic valve products on the market
  1. Subjects with severe aortic valve stenosis 2. Subjects who plan (or have) to use the transcatheter aortic valve replacement system for percutaneous aortic valve replacement 3. The patients agreed to join the study, voluntarily signed the informed consent and completed the follow-up; 4. Be able to contact the subjects or their legal guardians / relatives; 5. The medical record records the subjects who have died and can't get any contact information of the subjects（ (for dead cases only) Sign

Первичные конечные точки

• Primary end point: the incidence of all-cause death 12 months after operation [Срок оценки: 12 months after aortic valve replacement]

Вторичные конечные точки (8)

• The compound incidence of death, surgery, severe stroke, life-threatening bleeding, serious vascular complications and acute renal failure (within 30 days after operation); [Срок оценки: Within 30 days after aortic valve replacement]
• The implantation rate of permanent pacemaker within 30 days; [Срок оценки: Within 30 days after aortic valve replacement]
• All stroke (disabled or not disabled) within 12 months and 2, 3, 4 and 5 years [Срок оценки: 12 months and within 2, 3, 4 and 5 years]
• the incidence of life-threatening bleeding within 12 months and 2, 3, 4 and 5 years; [Срок оценки: 12 months and within 2, 3, 4 and 5 years]
• The incidence of reoperation due to dysfunction of prosthetic valve within 12 months and 2,3,4,5 years; [Срок оценки: 12 months and within 2, 3, 4 and 5 years]
• The incidence of readmission due to symptoms and signs of aortic valve disease within 12 months and 2,3,4,5 years; [Срок оценки: 12 months and within 2, 3, 4 and 5 years]
• The incidence of prosthetic valve dysfunction at 12 months (moderate or severe stenosis or reflux by ultrasonography); [Срок оценки: 12 months and within 2, 3, 4 and 5 years]
• The incidence of thrombus in clinical and subclinical prosthetic heart valves at 12 months; [Срок оценки: 12 months after aortic valve replacement]

Критерии участия

Критерии включения

• Severe aortic valve stenosis, defined as follows:

• Symptomatic patients:

• The mean differential pressure measured by echocardiography ≥ 40mm Hg
• Or peak aortic ejection ≥ 4.0 m / S
• Or aortic valve area ≤ 1.0cm ²（ Or AVA index ≤ 0.6 cm2 / m2)
• Asymptomatic patients:

• Severe aortic stenosis and aortic valve area ≤ 1.0cm ²（ 6 cm2 / m2) with aortic ejection peak value ≥ 5.0 M / s or mean pressure difference measured by --echocardiography ≥ 60 mm Hg;
• Or aortic valve area ≤ 1.0cm ²（ Or AVA index ≤ 0.6 cm2 / m2), combined with aortic ejection peak ≥ 4.0 m / s or average differential pressure measured by echocardiography ≥ 40 mm Hg, combined with limited exercise tolerance test, abnormal blood pressure response or arrhythmia;
• Or aortic valve area ≤ 1.0cm ²（ Or AVA index ≤ 0.6 cm2 / m2), combined with aortic ejection peak ≥ 4.0 m / s or average differential pressure measured by echocardiography ≥ 40 mm Hg, combined with LVEF < 50%
• Subjects who plan (or have) to use the transcatheter aortic valve replacement system for percutaneous aortic valve replacement
• The patients agreed to join the study, voluntarily signed the informed consent and completed the follow-up;
• Be able to contact the subjects or their legal guardians / relatives;
• The medical record records the subjects who have died and can't get any contact information of the subjects（ (for dead cases only)

Note: for dead subjects, they must meet 1, 2 and 5 at the same time before they can be included in the group.

Критерии исключения

• Contraindications to any artificial biological valve implantation;
• Any known allergies or contraindications;

• Aspirin or heparin and bivalirudin;
• Tigrelol and clopidogrel;
• Nickel titanium alloy;
• Contrast medium;
• The patient is currently participating in drug or device research;
• The patient is pregnant or lactating;
• Aortic annulus diameter < 17 mm or > 32 mm;
• The diameter of approach vessel was less than 5.0mm;
• The investigator believes that the patient is not suitable to participate in this study or complete the follow-up specified in the protocol;

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Fang Y, Wang H, Li Y, Zhao X, Wang B, Wang G, Liu D, Yan C, Xu K, Han Y. Identification of key diagnostic and prognostic biomarkers for aortic valve stenosis with coronary artery disease through immunological profiling integrating proteomics, single-cell sequencing, and machine learning. Biochem Biophys Res Commun. 2025 Nov 14;789:152855. doi: 10.1016/j.bbrc.2025.152855. Epub 2025 Oct 24. PMID 41151411

Идентификаторы

NCT: NCT04988243 · DB001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗