Hypertrophic Obstructive Cardiomyopathy
Conditions
Interventions
Surgical group:Pulse field ablation therapy for the hypertrophic area of the interventricular septum.
Sponsors
The First Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 75 years, any gender; 2. Diagnosis of Hypertrophic Obstructive Cardiomyopathy (HOCM) according to the 2024 AHA/ACC Guidelines for the Management of Hypertrophic Cardiomyopathy; 3. First-time candidate for septal reduction therapy; 4.LVOTG >= 50 mmHg at rest or during provocation (e.g., Valsalva maneuver); 5. Clear clinical history of syncope or presyncope episodes; 6. Poor response to or intolerance of side effects from sufficient GDMT (Guideline-Directed Medical Therapy); 7.Those who agree to participate in this study and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously undergone septal reduction therapy; 2. Left ventricular ejection fraction (LVEF) < 25%; 3. Echocardiography and cardiac MRI indicating isolated apical hypertrophy and non-obstructive hypertrophic cardiomyopathy; 4. History of sustained ventricular tachycardia, ventricular fibrillation, or cardiac arrest within the past 6 months; 5. Concurrent diseases requiring surgical intervention (severe organic mitral valve disease, need for coronary artery bypass grafting, or other cardiac diseases); 6. Patients with clear thrombus in the left atrium or heart, or patients with paroxysmal or persistent atrial fibrillation who have not received systemic anticoagulation therapy in the past 4 weeks; 7. Patients with second-degree (type II) or third-degree atrioventricular block; 8. Patients with significant congenital heart defects (such as atrial septal defect or severe pulmonary vein stenosis, excluding patent foramen ovale); 9. Patients with implanted artificial heart valves; 10. Patients with implanted pacemakers or implantable cardioverter-defibrillators (ICD); 11. Known symptomatic carotid artery stenosis before surgery; 12. Untreated or uncontrolled hyperthyroidism or hypothyroidism; 13. Patients with systemic active infections; 14. Patients with significant bleeding tendencies or undergoing dialysis for renal failure; 15. Patients who have had a myocardial infarction or any cardiac intervention/surgical procedure within the past 3 months; 16. Patients who have had a stroke or transient ischemic attack within the past 6 months; 17. Patients with obvious contraindications for intervention, as determined by the investigator, who cannot undergo ablation surgery; 18. Pregnant or breastfeeding women, or women planning to conceive during the study; 19. Patients who have participated in other clinical trials involving drugs or medical devices within the past 3 months; 20.Patients who, in the opinion of the investigator, are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left Ventricular Outflow Tract Pressure Gradient;Immediate success rate of surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of LVOTPG;walk test;the thickness of the ventricular septum;cardiac function;KCCQ scores; | — |
Countries
China
Contacts
Public ContactZhaojun Wang
The First Affiliated Hospital of Harbin Medical University
Outcome results
None listed