NCT05332691

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

Recruiting now NA Last updated 7 November 2024

What this trial tests

NA trial testing Transapical beating-heart septal myectomy in Hypertrophic Obstructive Cardiomyopathy in 1,000 participants. Currently enrolling.

Timeline

15 April 2022

Primary endpoint
30 December 2024

30 December 2025

Quick facts

Lead sponsor	Xiang Wei
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1,000
Start date	15 April 2022
Primary completion	30 December 2024
Estimated completion	30 December 2025
Sites	1 location across China

Drugs / interventions tested

• Transapical beating-heart septal myectomy

Conditions studied

• Hypertrophic Obstructive Cardiomyopathy — all drugs for Hypertrophic Obstructive Cardiomyopathy →

Sponsor

Xiang Wei

Who can join

8 and older, any sex, with Hypertrophic Obstructive Cardiomyopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. First-in-Human Transapical Beating-Heart Septal Myectomy in Patients With Hypertrophic Obstructive Cardiomyopathy.
   Fang J, Liu Y, Zhu Y, Li R, et al · · 2023 · cited 50× · PMID 37558369 · DOI 10.1016/j.jacc.2023.05.052
2. Transapical Beating-Heart Septal Myectomy for Obstructive Hypertrophic Cardiomyopathy: Lessons Learned After the Learning Curve Period.
   Fang J, Chen Y, Liu Y, Li R, et al · · 2025 · cited 11× · PMID 40315478 · DOI 10.1161/circinterventions.124.015044
3. Transapical beating heart septal myectomy learning curve and training of future surgeons: an observational study.
   Li J, Chen Y, Li R, Fang J, et al · · 2024 · cited 8× · PMID 39806738 · DOI 10.1097/js9.0000000000001797
4. Early left atrial reverse remodelling in patients with hypertrophic obstructive cardiomyopathy receiving transapical beating-heart septal myectomy.
   Lu S, Zhang J, Zhu Y, Zhou W, et al · · 2024 · cited 1× · PMID 39120116 · DOI 10.1093/icvts/ivae145
5. Anesthetic procedure for transapical beating-heart septal myectomy in patients with hypertrophic obstructive cardiomyopathy: Report of three cases.
   Xu Q, Li R, Liu Y, Chen Y, et al · · 2024 · PMID 41929421 · DOI 10.1016/j.jatmed.2024.10.002
6. Incremental Value of Apical Longitudinal Strain in Predicting High-Risk Apical Aneurysms in Patients with Hypertrophic Cardiomyopathy
   Hu X, Cheng X, Bao Y, Tian J, et al · · 2026
7. Transapical beating-heart septal myectomy for Fabry cardiomyopathy with left ventricular outflow tract obstruction: a retrospective case series.
   Tian J, Zhou W, Wang H, Bao Y, et al · · 2025 · PMID 41209281 · DOI 10.21037/qims-2025-893
8. Transapical Beating-Heart Septal Myectomy for Obstructive Hypertrophic Cardiomyopathy With Anomalous Papillary Muscle Insertion.
   Chen Y, Quintana E, Fang J, Liu Y, et al · · 2025 · PMID 40833749 · DOI 10.1093/icvts/ivaf195