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

NCT ID: NCT05957419

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2025-10-31

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.

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.

Conditions

Hypertrophic Obstructive Cardiomyopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypertrophic Obstructive Cardiomyopathy

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

Group Type: EXPERIMENTAL

Transapical beating-heart septal myectomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Minimally invasive transapical septal myectomy in the beating hearts

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: collaborator

Second Hospital of Jilin University

OTHER

Sponsor Role: collaborator

Xiang Wei

OTHER

Sponsor Role: lead

Responsible Party

Xiang Wei

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Xiang Wei, M.D.

Role: primary

xiangwei@tjh.tjmu.edu.cn

+8613995525956

Jing Fang, M.D.

Role: backup

jingfang@hust.edu.cn

+8613296640596

References

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.

Reference Type: RESULT

PMID: 31642911 (View on PubMed)

Other Identifiers

2023-S011

Identifier Type: -

Identifier Source: org_study_id