Hypertrophic Obstructive Cardiomyopathy (HOCM).
Conditions
Interventions
Experimental Group:Septal reduction therapy via three-dimensional magnetically navigated transvenous intramyocardial PFA (Pulsed Field Ablation).
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 70 years old, inclusive, regardless of gender. 2.Diagnosed with hypertrophic obstructive cardiomyopathy, echocardiography indicating left ventricular outflow tract obstruction, with a pressure gradient >50 mmHg and 15 mm and 50 mmHg at rest or during provocation test after 2 months of guideline-recommended medication) or patient intolerance/unwillingness to undergo pharmacological treatment. 5.Individuals who agree to participate in this clinical study and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Presence of valvular or associated structural abnormalities requiring surgical correction. 2.Documented ventricular arrhythmias and associated syncope. 3.Preoperative confirmation of left bundle branch block, or second-degree type II or higher atrioventricular block. 4.Patients with severe hepatic or renal insufficiency, deemed by the investigator as unsuitable for surgery. 5.Life expectancy of less than 1 year. 6.Patients with a history of any type of septal reduction surgery. 7.Patients who have experienced a myocardial infarction or undergone any cardiac interventional treatment (excluding coronary angiography)/open-heart surgery within the past three months. 8.Women who are pregnant or breastfeeding, or individuals planning to have children during the study period. 9.Patients currently participating in clinical trials of other drugs or medical devices. 10.Patients deemed by the investigator as unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of major safety events (SE) within 7 days post-operation.;Immediate success rate of the operation: The pressure gradient of the left ventricular outflow tract decreases by = 50% or the resting pressure gradient of the left ventricular outflow tract is less t; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical effective rate one month after the operation: One month after the operation, as determined by transthoracic echocardiography, the resting left ventricular outflow tract pressure gradient is l;Incidence rate of major complications; | — |
Countries
China
Contacts
Public ContactSuchen
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed