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

Hypertrophic Obstructive Cardiomyopathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05332691
• Other study ID #: 2022-S013
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Obstructive Cardiomyopathy
• Hypertrophy

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

External Links

•   Transapical septal myectomy in the beating heart via a minimally invasive approach: a feasibility study in swine