Transapical Beating-Heart Septal Myectomy for Symptomatic Nonobstructive Hypertrophic Cardiomyopathy

NCT05648825 | Active Not Recruiting DMC

• 1 other identifier: 2022-S086
• Study Type: interventional
• Target: 100
• 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 myectomy for the treatment of apical hypertrophic cardiomyopathy. This is a prospective, single-arm, single-center study.

Conditions

Nonobstructive Hypertrophic Cardiomyopathy

Keywords

Septal Myectomy; Transapical Beating-heart Septal Myectomy; Minimally Invasive; Midventricular obstruction and cavity obliteration; Nonobstructive Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Procedural success

  Kansas City Cardiomyopathy Questionnaire (KCCQ) score improvement of ≥10 points, New York Heart Association (NYHA) improvement ≥ 1 grade, stroke volume increased by ≥10 mL, and diastolic function grading at normal or grade I (of III) .

  6 months

Secondary Outcomes (23)

• Left ventricular end-diastolic pressure

  1 day

• Left ventricular end-systolic volume

  7 days and 6 months

• Left ventricular end-diastolic volume

  7 days and 6 months

• Obliteration

  6 months

• Peak oxygen consumption

  6 months

Study Arms (1)

Transapical beating-heart septal myectomy

EXPERIMENTAL

Transapical beating-heart myectomy for the treatment of nonobstructive hypertrophic cardiomyopathy

Device: Transapical beating-heart septal myectomy

Interventions

Transapical beating-heart septal myectomy DEVICE

We have invented a beating-heart myectomy device. Using this device, myectomy could be performed in the beating heart via a mini-thoractomy approach. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. We are now conducting the study to explore the feasibility, the safety, and the efficacy of transapical beating-heart myectomy for the treatment of nonobstructive hypertrophic cardiomyopathy.

Transapical beating-heart septal myectomy

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were diagnosed as nonobstructive hypertrophic cardiomyopathy, with maximal apical wall thickness ≥ 15 mm.
• Patients with heart function of New York Heart Association ≥ class II.
• Presenting with severe symptoms, e.g. angina, dyspnea, or fatigue, that were unresponsive or intolerant to pharmaceutical therapies;
• Kansas City Cardiomyopathy Questionnaire (KCCQ) score \< 80;
• Presenting with one of the following conditions: midventricular obstruction with gradient ≥ 50 mmHg; grade II or higher diastolic dysfunction; apical aneurysm; ventricular tachycardia that needed an ICD implantation; pulmonary hypertension.
• 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-chamber cardiac surgery.
• Patients who had severe heart failure with left ventricle ejection fraction \< 50%.
• Patients whose estimated life expectancy \< 12 months.
• Patient who were non-compliant.
• peak VO2 of cardiopulmonary exercise test ≥ 90% of predicted.
• LVOT obstruction.
• 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

Study Sites (1)

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

Wuhan, Hubei, 430000, China

Location

Related Publications (2)

• 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 BACKGROUND

• Schaff HV, Brown ML, Dearani JA, Abel MD, Ommen SR, Sorajja P, Tajik AJ, Nishimura RA. Apical myectomy: a new surgical technique for management of severely symptomatic patients with apical hypertrophic cardiomyopathy. J Thorac Cardiovasc Surg. 2010 Mar;139(3):634-40. doi: 10.1016/j.jtcvs.2009.07.079.

  PMID: 20176208 BACKGROUND

Study Officials

• Xiang Wei, M.D.

  Tongji Hospital

  STUDY CHAIR

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: Division of Cardiothoracic and Vascular Surgery

Model Details: Beating-Heart Myectomy Device

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: November 15, 2022
• Primary Completion: July 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

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)