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 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT07077005
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years of age
* Diagnosis of hypertrophic obstructive cardiomyopathy
* ≥12 weeks of unchanged dosage of mavacamten
* Peak left ventricular outflow tract gradient ≤ 50 mmHg at rest and during stress echocardiography
* Left ventricular ejection fraction ≥50% at study inclusion
* New York Heart Association classes I-II
Exclusion Criteria:
* Syncope or sustained ventricular tachycardia within 6 months prior to study inclusion
* Corrected QT-interval (Fridericia-formula) ≥ 500 ms
* Paroxysmal or intermittent atrial fibrillation (AF) on screening electrocardiogram
* Persistent or permanent AF without anticoagulation for ≥4 weeks
* Previous transcoronary ablation of septal hypertrophy or surgical myectomy
* Ventricular tachycardia, significant ST-elevation or depression upon baseline cardiopulmonary exercise testing
* ≥ grade II valve insufficiencies or stenoses during resting echocardiography
* Prior implantable cardioverter defibrillator-implantation
* Sudden Cardiac Death Risk Score ≥4%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT07077005
Study Brief:
Protocol Section:
NCT07077005