NCT05332691Recruiting
Transapical Beating-heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy
Minimally Invasive Transapical Septal Myectomy in the Beating Hearts for the Treatment of Hypertrophic Obstructive Cardiomyopathy: Safety and Efficacy Results of a Phase I First-in-man Clinical Trial
Source: ClinicalTrials.gov · Last updated 7 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 11 Apr 2022
- Start date
- 15 Apr 2022
- Primary completion date
- 30 Dec 2024
- Lead sponsor
- Xiang Wei
- NCT number
- NCT05332691
What you commit to
- Study type: Interventional
- Planned participants: 1000
- From 15 Apr 2022 to the primary completion date, 30 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-heart surgery.
Lab values
- Patients who had severe heart failure with left ventricle ejection fraction \< 40%.
Other
- Patients who were pregnant.
- 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.
Who the study is looking for
- 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.
Age in the registry: 8 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.