New heart surgery technique for patients with hypertrophic obstructive 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 transapical beating-heart septal myectomy for treating hypertrophic obstructive cardiomyopathy. The procedure aims to relieve left ventricle outflow tract obstruction while minimizing surgical injury through a mini-thoracotomy approach. Real-time echocardiography is utilized to monitor and navigate the surgery, ensuring precise resection and evaluation of outcomes. Patients will be followed up at discharge and three months post-operation to assess their recovery and symptom relief.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients whose resting or provoked left ventricular outflow tract gradient \> 50 mmHg, and 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.

• Hypertrophic Cardiomyopathy Registry, Biobank, and Imaging Data Repository

  This project tests whether collecting genetic, imaging, and clinical data from people with hypertrophic cardiomyopathy can help predict outcomes and better understand the disease.

  Recruiting at 15 sites Montreal Heart Institute · Edmonton, Alberta and 16 other locations · NCT05100420

• Assessing health changes in patients with obstructive hypertrophic cardiomyopathy treated with mavacamten

  This study is testing how well the medication mavacamten helps adults with obstructive hypertrophic cardiomyopathy feel and do better in their everyday lives.

  Recruiting Bristol-Myers Squibb · Boston, Massachusetts · NCT06551129

• Assessing the safety of mavacamten in Korean patients with obstructive hypertrophic cardiomyopathy

  This study is testing how safe the medication mavacamten is for adults in Korea who have symptoms of obstructive hypertrophic cardiomyopathy.

  Recruiting Bristol-Myers Squibb · Seoul and 1 other locations · NCT06146660

• Effect of mavacamten on heart blood flow in obstructive hypertrophic cardiomyopathy

  This study is testing if the medication mavacamten can improve blood flow in the hearts of people with obstructive hypertrophic cardiomyopathy after a year of treatment.

  Recruiting University of Virginia · Charlottesville, Virginia · NCT06023186

• Registry to assess patient characteristics and outcomes in obstructive hypertrophic cardiomyopathy

  This study is trying to learn more about how people with obstructive hypertrophic cardiomyopathy are treated and what their experiences are, especially for those using the medication mavacamten.

  Recruiting at 76 sites Bristol-Myers Squibb · Anchorage, Alaska and 100 other locations · NCT05489705

• Mavacamten outcomes and real-world patient and physician experiences for obstructive HCM in the US

  See how mavacamten works and what patients and doctors experience for adults with obstructive hypertrophic cardiomyopathy treated in US community practice.

  Recruiting Bristol-Myers Squibb · Bollington, Macclesfield · NCT07557498

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.