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Transapical Beating-Heart Septal Myectomy for Symptomatic Nonobstructive Hypertrophic Cardiomyopathy

NCT05648825 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-08

No results posted yet for this study

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

Interventions

DEVICE

Transapical beating-heart septal myectomy

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.

Sponsors & Collaborators

  • Xiang Wei

    lead OTHER

Principal Investigators

  • Xiang Wei, M.D. · Tongji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2025-07-30
Completion
2026-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05648825 on ClinicalTrials.gov