Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis

Официальное название

A Prospective, Single-center, Single-group Follow-up Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis by Peijia Medical

Обзор

A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical

Подробное описание

A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medica.Patients are seen at pre and post procedure, discharge, 30 days. The main follow-up included clinical symptoms and signs, cardiac ultrasound, CT, etc. The outcome include immediate device success, procedure success and device sucess. The secondary end points include ：1) Immediate postoperative ultrasound evaluation of different sinus valve implantation depths.2) realization rate of commissural alignment was evaluated by ultrasound immediately after operation.3) the incidence of ≥ moderate paravalvular regurgitation assessed by ultrasound at 30 days after surgery.

4\) CT assessment of different sinus valve implantation depths at 30 days after surgery.5) CT was performed 30 days after operation to evaluate the realization rate of commissural alignment and coronary artery alignment

Вмешательства

• Устройство transcatheter aortic valve replacement in severe aortic stenosis
  transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis

Первичные конечные точки

• Device success rate [Срок оценки: at 30 days]

Критерии участия

Критерии включения

• Patients who are willing to participate and sign the informed consent and can cooperate with the whole trial process;
• Age ≥60 years old;
• Patients with severe calcified aortic stenosis confirmed by echocardiography (trans-aortic valve flow velocity ≥ 4.0m /s, or trans-active valvular pressure difference ≥40mmHg (1mmHg=0.133kPa), or aortic valve orientation area < 0.8cm2, or effective aortic valve orifice the product index is < 0.5cm2/m2);
• The cardiac team (at least two specialists in cardiovascular surgery) assessed the patient as unsuitable for routine surgery ;
• The aortic angel ≥60 degree.

Критерии исключения

• The left and right coronary ostiums originate from the junctional zone or from both coronary ostiums;
• previous CABG history;
• Coronary ostial lesions（PCI or not）;
• Prior aortic valve prosthesis implantation (interventional/surgical, bioprosthetic/mechanical);
• Spoor peripheral arterial condition precluded transfemoral TAVR;
• Severe coronary stenoses requiring intervention for which concomitant PCI is not possible;
• Concomitant diseases requiring cardiac surgery;
• Other serious diseases that may reduce life expectancy to less than 12 months (e.g. clinically recurrent or metastatic cancer, congestive heart failure, etc.);
• contraindications to conventional cardiac catheterization, such as intracardiac thrombosis, infection, outflow obstruction, hypertrophic cardiomyopathy, etc;
• other surgical anatomical contraindications, such as the risk of coronary artery occlusion;
• clinically significant active bleeding
• platelet count < 30×10/ L;
• participating in other drug or medical device clinical studies that have not yet been completed ;
• considered inappropriate by the investigator to participate in the clinical study.

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

• Peiga Medical Technology (Suzhou) Co., Ltd, Suzhou, Jiangsu 215025 — Сучжоу

Публикации

• Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. PMID 30883058
• Vinayak M, Tang GHL, Li K, Berdan M, Koshy AN, Khera S, Lerakis S, Dangas GD, Sharma SK, Kini AS, Krishnamoorthy P. Commissural vs Coronary Alignment to Avoid Coronary Overlap With THV-Commissure in TAVR: A CT-Simulation Study. JACC Cardiovasc Interv. 2024 Mar 25;17(6):715-726. doi: 10.1016/j.jcin.2024.01.073. Epub 2024 Mar 6. PMID 38456886
• Bieliauskas G, Wong I, Bajoras V, Wang X, Kofoed KF, De Backer O, Sondergaard L. Patient-Specific Implantation Technique to Obtain Neo-Commissural Alignment With Self-Expanding Transcatheter Aortic Valves. JACC Cardiovasc Interv. 2021 Oct 11;14(19):2097-2108. doi: 10.1016/j.jcin.2021.06.033. Epub 2021 Sep 15. PMID 34538602

Идентификаторы

NCT: NCT06721676 · B2024-496

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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