Transapical Beating-Heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy: a Multi-Center Study

Sponsor

Xiang Wei (Other)

Overall Status

Recruiting

CT.gov ID

NCT05957419

Collaborator

Guangdong Provincial People's Hospital (Other), Beijing Anzhen Hospital (Other), Fudan University (Other), Second Hospital of Jilin University (Other)

1,000

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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, multi-center study.

Condition or Disease	Intervention/Treatment	Phase
Hypertrophic Obstructive Cardiomyopathy	Procedure: Transapical beating-heart septal myectomy	N/A

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, the investigators 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, participants is scheduled to be seen for follow-up visits at discharge (about 7 days post operation) and 3 months.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single Group Assignment Beating-heart myectomy deviceSingle Group Assignment Beating-heart myectomy device

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Minimally Invasive Transapical Septal Myectomy in the Beating Hearts for the Treatment of Hypertrophic Obstructive Cardiomyopathy: a Multi-Center Study

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hypertrophic Obstructive Cardiomyopathy Transapical beating-heart septal myectomy for the patient with hypertrophic obstructive cardiomyopathy.	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. Other Names: Minimally invasive transapical septal myectomy in the beating hearts

Arm

Intervention/Treatment

Experimental: Hypertrophic Obstructive Cardiomyopathy

Transapical beating-heart septal myectomy for the patient with hypertrophic obstructive cardiomyopathy.

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.

Other Names:

Minimally invasive transapical septal myectomy in the beating hearts

Outcome Measures

Primary Outcome Measures

All-cause mortality [3 months]
Death from any cause during the observation period.
Number of participants with procedural success [3 months]
Resting left ventricle outflow tract gradients < 30 mmHg, provoked left ventricle outflow tract gradients < 50 mmHg, and mitral regurgitation (MR) ≤ grade 1+.

Secondary Outcome Measures

Number of participants with device success [1 day]
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.
Septal thickness [7 days and 3 months]
Basal and mid septal thickness as measured by echocardiography.
Left ventricle mass [7 days and 3 months]
Left ventricle mass index (the ratio of left ventricle mass to body weight) as measured by cardiac magnetic resonance.
Left atria volume [7 days and 3 months]
The left atria volume as measured by echocardiography.
Major adverse cardiovascular and cerebral events [3 months]
In-hospital mortality, atrioventricular block that need permanent pacemaker implantation, sternotomy conversion, iatrogenic ventricular septal perforation, iatrogenic valvular injury, imaging examination-validated cerebral complications.
New York Heart Association class [7 days and 3 months]
New York Heart Association class, including grade I, grade II, grade III, grade IV. A higher grade means worse heart function.
6-minute walking test [3 months]
6-minute walking test. A longer distance means better heart function.
Score of the Kansas City Cardiomyopathy Questionnaire [7 days and 3 months]
The score of the Kansas City Cardiomyopathy Questionnaire have a range 0-100. A higher score means better heart function.
Left ventricular outflow tract gradient [7 days and 3 months]
Left ventricular outflow tract gradient as measured by echocardiography.
Grade of mitral regurgitation [7 days and 3 months]
Grade of mitral regurgitation as measured by echocardiography, with a scale of 0, 1+, 2+, 3+, 4+. A higher grade means worse mitral regurgitaion.
Left ventricular outflow tract diameter [7 days and 3 months]
Left ventricular outflow tract diameter as measured by echocardiography.
Number of Participants with technical success [7 days or before discharge]
Resting left ventricle outflow tract gradients < 30 mmHg without in-hospital death.
Grade of systolic anterior motion [7 days and 3 months]
Grade of systolic anterior motion as measured by echocardiography, with a scale of 0, 1, 2, 3, 4. A higher grade means worse mitral regurgitaion.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.