Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT07006493
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 80 years, regardless of sex
* Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM)
* Presence of significant symptoms (e.g., dyspnea, chest pain, fatigue, palpitations, syncope)
* NYHA class II or higher with LVOTG ≥50 mmHg at rest or provoked (assessed by echocardiography)
* Septal thickness ≥15 mm
* Unsuitable for surgical myectomy or refusal of surgery
* Provided informed consent and agree to complete follow-up
Exclusion Criteria:
* Asymptomatic or non-obstructive HCM
* Septal thickness ≥30 mm
* Mitral valve anatomy not suitable for ablation as judged by investigator
* High risk of sudden cardiac death (SCD) requiring ICD implantation
* Complete right bundle branch block at screening
* Infective endocarditis, myocarditis, atrial myxoma, or intracardiac thrombus
* Contraindication to transseptal access (e.g., septal patch)
* Mechanical valves or history of aortic valve replacement
* Severe heart failure with persistent symptoms and LVEF \<40%
* Major cardiac events within 6 months (e.g., cardiac arrest, MI, heart failure hospitalization)
* Significant structural heart disease requiring surgery
* Prior septal reduction therapy or pacemaker implantation
* Constrictive pericarditis or significant congenital heart disease
* Bleeding disorders or contraindication to antithrombotic therapy
* Liver dysfunction (ALT/AST \>3× ULN)
* Renal insufficiency (creatinine \>2.0 mg/dL or on dialysis)
* Pregnant, breastfeeding, or planning pregnancy within 6 months post-op
* Life expectancy \<12 months
* Participation in other investigational studies within 30 days or 5 half-lives
* Investigator determines poor compliance or unsuitability
* Contraindications to cardiac MRI (e.g., ICD, allergy to contrast, claustrophobia)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07006493
Study Brief:
Protocol Section:
NCT07006493