Actively Recruiting

Phase Not Applicable
Age: 8Years +
All Genders
NCT05332691

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

Led by Xiang Wei · Updated on 2024-11-07

1000

Participants Needed

1

Research Sites

193 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 8Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with left ventricular outflow tract gradient over 50 mmHg and septal wall thickness of 15 mm or more
  • Patients with heart function at New York Heart Association class II or higher
  • Patients with symptoms that do not improve with medication or who cannot tolerate drug treatments
  • Patients who understand the trial and have signed informed consent
Not Eligible

You will not qualify if you...

  • Pregnant patients
  • Patients with other heart diseases needing open-heart surgery, such as valvular disease or coronary artery disease
  • Patients with severe heart failure and left ventricle ejection fraction below 40%
  • Patients with life expectancy less than 12 months
  • Patients who are non-compliant
  • Patients deemed unsuitable for the trial by the medical team

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Wuhan, Hubei, China, 430000

Actively Recruiting

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Research Team

X

Xiang Wei, M.D.

CONTACT

J

Jing Fang, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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