Surgery to treat heart issues in patients with nonobstructive hypertrophic cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the feasibility, safety, and efficacy of a novel surgical technique called transapical beating-heart septal myectomy for patients suffering from nonobstructive hypertrophic cardiomyopathy. The procedure aims to alleviate drug-refractory heart failure symptoms by performing septal resection through a minimally invasive approach while the heart is still beating. The surgery is guided by real-time echocardiography to ensure precision and safety. The study is a prospective, single-arm, single-center trial conducted at Tongji Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients whose maximal ventricular septal wall thickness ≥ 15 mm.
2. Patients with heart function of New York Heart Association ≥ class II.
3. Patients with drug-refractory symptoms or intolerable to pharmaceutical therapies.
4. 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:

1. Patients who were pregnant.
2. Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-heart surgery.
3. Patients who had severe heart failure with left ventricle ejection fraction \< 40%.
4. Patients whose estimated life expectancy \< 12 m.
5. Patient who were non-compliant.
6. 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.

Where it's running

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Xiang Wei, M.D.
• Email: xiangwei@tjh.tjmu.edu.cn
• Phone: +8613995525956

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• HTX-001: a first-in-human test to see if this daily shot is safe for adults with nonobstructive hypertrophic cardiomyopathy

  This study tests multiple doses of HTX-001, an injectable antisense therapy, to see if it is safe and how it behaves in the body for adults with nonobstructive hypertrophic cardiomyopathy already on standard care.

  Recruiting at 3 sites Phase 1 Haya Therapeutics, Inc. · Boston, Massachusetts and 2 other locations · NCT07867288

• Enavogliflozin for treating diastolic dysfunction in nonobstructive hypertrophic cardiomyopathy

  This study is testing if the medication enavogliflozin can help people with nonobstructive hypertrophic cardiomyopathy feel better and improve their heart function compared to a placebo over 24 weeks.

  Recruiting Phase 4 Yonsei University · Seoul · NCT06580717

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.