Hypertrophic Obstructive Cardiomyopathy Clinical Trial
Official title:
Minimally Invasive Transapical Septal Myectomy in the Beating Hearts for the Treatment of Hypertrophic Obstructive Cardiomyopathy: a Multi-Center Study
NCT number | NCT05957419 |
Other study ID # | 2023-S011 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2023 |
Est. completion date | October 2025 |
Verified date | July 2023 |
Source | Tongji Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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, multi-center study.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | October 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Xiang Wei | Beijing Anzhen Hospital, Fudan University, Guangdong Provincial People's Hospital, Second Hospital of Jilin University |
China,
Fang J, Wang R, Liu H, Su Y, Chen J, Han X, Wei Y, Chen Y, Cheng L, Wei X. Transapical septal myectomy in the beating heart via a minimally invasive approach: a feasibility study in swine. Interact Cardiovasc Thorac Surg. 2020 Feb 1;30(2):303-311. doi: 10 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause mortality | Death from any cause during the observation period. | 3 months | |
Primary | Number of participants with procedural success | Resting left ventricle outflow tract gradients < 30 mmHg, provoked left ventricle outflow tract gradients < 50 mmHg, and mitral regurgitation (MR) = grade 1+. | 3 months | |
Secondary | Number of participants with device success | Successful accession, delivery, and retrieval of the resection device, successful resection of the septal myocardium, resting left ventricle outflow tract gradient less than 50 mmHg and mitral regurgitation (MR) = grade 2+ during operation after resection, and free from conversion to midline thoracotomy during operation. | 1 day | |
Secondary | Septal thickness | Basal and mid septal thickness as measured by echocardiography. | 7 days and 3 months | |
Secondary | Left ventricle mass | Left ventricle mass index (the ratio of left ventricle mass to body weight) as measured by cardiac magnetic resonance. | 7 days and 3 months | |
Secondary | Left atria volume | The left atria volume as measured by echocardiography. | 7 days and 3 months | |
Secondary | Major adverse cardiovascular and cerebral events | In-hospital mortality, atrioventricular block that need permanent pacemaker implantation, sternotomy conversion, iatrogenic ventricular septal perforation, iatrogenic valvular injury, imaging examination-validated cerebral complications. | 3 months | |
Secondary | New York Heart Association class | New York Heart Association class, including grade I, grade II, grade III, grade IV. A higher grade means worse heart function. | 7 days and 3 months | |
Secondary | 6-minute walking test | 6-minute walking test. A longer distance means better heart function. | 3 months | |
Secondary | Score of the Kansas City Cardiomyopathy Questionnaire | The score of the Kansas City Cardiomyopathy Questionnaire have a range 0-100. A higher score means better heart function. | 7 days and 3 months | |
Secondary | Left ventricular outflow tract gradient | Left ventricular outflow tract gradient as measured by echocardiography. | 7 days and 3 months | |
Secondary | Grade of mitral regurgitation | Grade of mitral regurgitation as measured by echocardiography, with a scale of 0, 1+, 2+, 3+, 4+. A higher grade means worse mitral regurgitaion. | 7 days and 3 months | |
Secondary | Left ventricular outflow tract diameter | Left ventricular outflow tract diameter as measured by echocardiography. | 7 days and 3 months | |
Secondary | Number of Participants with technical success | Resting left ventricle outflow tract gradients < 30 mmHg without in-hospital death. | 7 days or before discharge | |
Secondary | Grade of systolic anterior motion | Grade of systolic anterior motion as measured by echocardiography, with a scale of 0, 1, 2, 3, 4. A higher grade means worse mitral regurgitaion. | 7 days and 3 months |
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