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

NCT05957419 | Unknown

• 1 other identifier: 2023-S011
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Obstructive Cardiomyopathy

Keywords

Hypertrophic Obstructive Cardiomyopathy; Septal Myectomy; Systolic Anterior Motion; Left Ventricle Outflow Tract Obstruction; Mitral Regurgitation; Transapical; Off-pump; Minimally invasive

Outcome Measures

Primary Outcomes (2)

• All-cause mortality

  Death from any cause during the observation period.

  3 months

• Number of participants with 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 Outcomes (13)

• Number of participants with device success

  1 day

• Septal thickness

  7 days and 3 months

• Left ventricle mass

  7 days and 3 months

• Left atria volume

  7 days and 3 months

• Major adverse cardiovascular and cerebral events

  3 months

Study Arms (1)

Hypertrophic Obstructive Cardiomyopathy

EXPERIMENTAL

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

Procedure: Transapical beating-heart septal myectomy

Interventions

Transapical beating-heart septal myectomy 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.

Also known as: Minimally invasive transapical septal myectomy in the beating hearts

Hypertrophic Obstructive Cardiomyopathy

Eligibility Criteria

• Age: 8 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiang Wei: lead
• Guangdong Provincial People's Hospital: collaborator
• Beijing Anzhen Hospital: collaborator
• Fudan University: collaborator
• Second Hospital of Jilin University: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430000, China

RECRUITING

Related 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.

  PMID: 31642911 RESULT

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Single Group Assignment Beating-heart myectomy device

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 24, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the current study is published.
• Access Criteria: All readers who were interested in the current study.

Locations

CN (1)