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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05332691
Other study ID # 2022-S013
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 15, 2022
Est. completion date July 15, 2023

Study information

Verified date December 2022
Source Tongji Hospital
Contact Xiang Wei, M.D.
Phone +8613995525956
Email xiangwei@tjh.tjmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date July 15, 2023
Est. primary completion date April 15, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years to 80 Years
Eligibility Inclusion Criteria: 1. Patients whose resting or provoked left ventricular outflow tract gradient > 50 mmHg, and maximal ventricular septal wall thickness = 15 mm. 2. Patients with heart function of New York Heart Association = class II. 3. Patients with drug-refractory symptoms or intolerable to pharmaceutical therapies. 4. 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: 1. Patients who were pregnant. 2. Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-heart surgery. 3. Patients who had severe heart failure with left ventricle ejection fraction < 40%. 4. Patients whose estimated life expectancy < 12 m. 5. Patient who were non-compliant. 6. 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.

Study Design


Related Conditions & MeSH terms


Intervention

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 muscular resection for sufficient relief of left ventricle outlet tract obstruction and mitral regurgitation, while preventing iatrogenic injuries.

Locations

Country Name City State
China Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Xiang Wei

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality Death from any cause during the observation period. 3 months
Primary Procedural success Resting left ventricle outflow tract gradients < 30 mmHg, provoked left ventricle outflow tract gradients < 50 mmHg, and mitral regurgitation (MR) = grade 1+. 3 months
Secondary Device success Successful accession, delivery, and retrieval of the resection device, successful resection of the septal myocardium, resting left ventricle outflow tract gradient less than 50 mmHg and mitral regurgitation (MR) = grade 2+ during operation after resection, and free from conversion to midline thoracotomy during operation. 1 day
Secondary Septal thickness Basal and mid septal thickness as measured by echocardiography. 7 days and 3 months
Secondary Left ventricle mass Left ventricle mass index (the ratio of left ventricle mass to body weight) as measured by cardiac magnetic resonance. 3 months
Secondary Left ventricle volume Left ventricle end-diastolic volume as measured by echocardiography. 7 days and 3 months
Secondary Cardiac diastolic function The ratio between early mitral inflow velocity and mitral annular early diastolic velocity ( E/e') as measured by echocardiography. 7 days and 3 months
Secondary Left atria volume The left atria volume as measured by echocardiography. 7 days and 3 months
Secondary Major adverse cardiovascular and cerebral events In-hospital mortality, atrioventricular block that need permanent pacemaker implantation, sternotomy conversion, iatrogenic ventricular septal perforation, iatrogenic valvular injury, imaging examination-validated cerebral complications. 3 months
Secondary New York Heart Association class New York Heart Association class, including grade I, grade II, grade III, grade IV. A higher grade means worse heart function. 7 days and 3 months
Secondary 6-minute walking test 6-minute walking test. A longer distance means better heart function. 3 months
Secondary Heart function-associated quality of life Score of the Kansas City Cardiomyopathy Questionnaire. A higher score means better heart function. 7 days and 3 months
Secondary Left ventricular outflow tract gradient Left ventricular outflow tract gradient as measured by echocardiography. 7 days and 3 months
Secondary Evaluation of the mitral valve Grade of mitral regurgitation and systolic anterior motion as measured by echocardiography. 7 days and 3 months
Secondary Left ventricular outflow tract diameter Left ventricular outflow tract diameter as measured by echocardiography. 7 days and 3 months
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