RecruitingNot Applicable

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

China1,000 participantsStarted 2022-04-15

Plain-language 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, single-center, first-in-man study.

Who can participate

Age range8 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

All-cause mortality

Timeframe: 3 months

Procedural success

Timeframe: 3 months

Trial details

NCT IDNCT05332691

SponsorXiang Wei

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-30

Contact for this trial

Xiang Wei, M.D.

+8613995525956 xiangwei@tjh.tjmu.edu.cn

View on ClinicalTrials.gov More Hypertrophic Obstructive Cardiomyopathy trials