Transapical Beating-heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transapical beating-heart septal myectomy.
- Who it may be relevant to
- Registry conditions: Hypertrophic Obstructive Cardiomyopathy. Basic parameters: from 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Procedure 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
Primary outcome measures
- All-cause mortality [Time frame: 3 months]
- Procedural success [Time frame: 3 months]
Secondary outcome measures (12)
- Device success [Time frame: 1 day]
- Septal thickness [Time frame: 7 days and 3 months]
- Left ventricle mass [Time frame: 3 months]
- Left ventricle volume [Time frame: 7 days and 3 months]
- Cardiac diastolic function [Time frame: 7 days and 3 months]
- Left atria volume [Time frame: 7 days and 3 months]
- Major adverse cardiovascular and cerebral events [Time frame: 3 months]
- New York Heart Association class [Time frame: 7 days and 3 months]
- 6-minute walking test [Time frame: 3 months]
- Heart function-associated quality of life [Time frame: 7 days and 3 months]
- Left ventricular outflow tract gradient [Time frame: 7 days and 3 months]
- Evaluation of the mitral valve [Time frame: 7 days and 3 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Publications
- 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
Identifiers
NCT: NCT05332691 · 2022-S013 2022-N016