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:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT03863132
Eligibility Criteria:
Inclusion Criteria:
* I1. Patients with symptomatic native aortic valve stenosis and age ≥18 years
* I2. Aortic valve area (AVA) ≤ 1 cm2 or indexed AVA ≤ 0.6 cm2/m2, mean aortic gradient \< 40 mmHg and stroke volume index (SVI) \< 35ml/m2
* I3. Left ventricular ejection fraction ≥ 50%
* I4. MDCT aortic valve calcium score men \> 2000AU, women \> 1200AU OR the likelihood criteria are fulfilled (symptoms without other explanation and LV hypertrophy; age \< 70 yrs., AVS \< 0.8 cm2; SVI \< 35ml/m2 confirmed by 3D TOE, MRI or invasive; reduced LV longitudinal function without other reason)
* I5. Heart team agrees on eligibility for TAVR
* I6. Written informed consent
* I7. Negative pregnancy test in women with childbearing potential
Exclusion Criteria:
* E1. Hemodynamic instability
* E2. Cardiogenic shock
* E3. Pre-existing mechanical or bio-prosthetic valve in any position
* E4. Concomitant severe valvular heart disease
* E5. Pre-existing or active endocarditis
* E6. Need for heart surgery due to other conditions
* E7. Aortic valve is congenital unicuspid or congenital bicuspid
* E8. Hypertrophic cardiomyopathy with or without obstruction
* E9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
* E10. Acute myocardial infarction within 1 month before intended AS-treatment
* E11. Renal replacement therapy
* E12. Estimated life expectancy \< 24 months (730 days) due to carcinomas end stage liver disease or renal disease
* E13. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
* E14. Patient refuses aortic valve repair
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03863132
Study Brief:
Protocol Section:
NCT03863132