Transapical Beating-heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy

Официальное название

Minimally Invasive Transapical Septal Myectomy in the Beating Hearts for the Treatment of Hypertrophic Obstructive Cardiomyopathy: Safety and Efficacy Results of a Phase I First-in-man Clinical Trial

Обзор

The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of hypertrophic obstructive cardiomyopathy. This is a prospective, single-arm, single-center, first-in-man study.

Подробное описание

Surgical septal myectomy remains the gold standard for the treatment of hypertrophic obstructive cardiomyopathy. However, conventional septal myectomy is hindered by the demanding expertise that is needed to sufficient relieve the obstruction of the left ventricle outflow tract while guarantee safety. To increase the visualization and minimize the surgical injury of conventional septal myectomy, we have invented a novel beating-heart myectomy device. Through a mini-thoractomy, septal myectomy could be accomplished via a transapical access in the beating heart using the beating-heart myectomy device. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. Left ventricle outflow tract gradient and the grade of mitral regurgitation are evaluated each time after resection. Multiple resections are performed to tailor sufficient relief of left ventricle outflow tract obstruction and mitral regurgitation, while preventing iatrogenic injuries. After transapical beating-heart septal myectomy, patients is scheduled to be seen for follow-up visits at discharge (about 7 days post operation) and 3 months.

Вмешательства

• Процедура Transapical beating-heart septal myectomy
  We have invented a beating-heart myectomy device.Through a minimally invasive intercostal incision, septal myectomy could be accomplished via a transapical access in the beating heart using the device. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. Left ventricle outlet tract gradient and the grade of mitral regurgitation are evaluated each time after resection. Multiple resections are performed to tailor the

Первичные конечные точки

• All-cause mortality [Срок оценки: 3 months]
• Procedural success [Срок оценки: 3 months]

Вторичные конечные точки (12)

• Device success [Срок оценки: 1 day]
• Septal thickness [Срок оценки: 7 days and 3 months]
• Left ventricle mass [Срок оценки: 3 months]
• Left ventricle volume [Срок оценки: 7 days and 3 months]
• Cardiac diastolic function [Срок оценки: 7 days and 3 months]
• Left atria volume [Срок оценки: 7 days and 3 months]
• Major adverse cardiovascular and cerebral events [Срок оценки: 3 months]
• New York Heart Association class [Срок оценки: 7 days and 3 months]
• 6-minute walking test [Срок оценки: 3 months]
• Heart function-associated quality of life [Срок оценки: 7 days and 3 months]
• Left ventricular outflow tract gradient [Срок оценки: 7 days and 3 months]
• Evaluation of the mitral valve [Срок оценки: 7 days and 3 months]

Критерии участия

Критерии включения

• Patients whose resting or provoked left ventricular outflow tract gradient > 50 mmHg, and maximal ventricular septal wall thickness ≥ 15 mm.
• Patients with heart function of New York Heart Association ≥ class II.
• Patients with drug-refractory symptoms or intolerable to pharmaceutical therapies.
• Patients who was informed the nature of the clinical trial, consented to participate in all of the activities of the clinical trial, and signed the informed consent form.

Критерии исключения

• Patients who were pregnant.
• Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-heart surgery.
• Patients who had severe heart failure with left ventricle ejection fraction < 40%.
• Patients whose estimated life expectancy < 12 m.
• Patient who were non-compliant.
• Patients under circumstances which were considered not suitable or prohibitive for participating the clinical trial at the discretion of the attending medical team and the researchers.

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

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань

Публикации

• Fang J, Wang R, Liu H, Su Y, Chen J, Han X, Wei Y, Chen Y, Cheng L, Wei X. Transapical septal myectomy in the beating heart via a minimally invasive approach: a feasibility study in swine. Interact Cardiovasc Thorac Surg. 2020 Feb 1;30(2):303-311. doi: 10.1093/icvts/ivz249. PMID 31642911
• Chen Y, Quintana E, Fang J, Liu Y, Wei X. Transapical Beating-Heart Septal Myectomy for Obstructive Hypertrophic Cardiomyopathy With Anomalous Papillary Muscle Insertion. Interdiscip Cardiovasc Thorac Surg. 2025 Sep 2;40(9):ivaf195. doi: 10.1093/icvts/ivaf195. PMID 40833749
• Fang J, Chen Y, Liu Y, Li R, Zhu Y, Zhou W, Cheng L, Wang Q, Shi J, Wei Y, Ma Y, Quintana E, Grau JB, Wan S, Wei X. Transapical Beating-Heart Septal Myectomy for Obstructive Hypertrophic Cardiomyopathy: Lessons Learned After the Learning Curve Period. Circ Cardiovasc Interv. 2025 May;18(5):e015044. doi: 10.1161/CIRCINTERVENTIONS.124.015044. Epub 2025 May 2. PMID 40315478
• Fang J, Liu Y, Zhu Y, Li R, Wang R, Wang DW, Song Y, Li C, Chen Y, Cheng L, Zheng K, Zhao Y, Li S, Cheng C, Xia L, Chen X, Wan S, Wei X. First-in-Human Transapical Beating-Heart Septal Myectomy in Patients With Hypertrophic Obstructive Cardiomyopathy. J Am Coll Cardiol. 2023 Aug 15;82(7):575-586. doi: 10.1016/j.jacc.2023.05.052. PMID 37558369

Идентификаторы

NCT: NCT05332691 · 2022-S013 2022-N016

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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