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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT03779620
Eligibility Criteria:
Inclusion Criteria:
1. Subjects suffering from severe symptomatic aortic valve stenosis (including subjects with a bicuspid valve).
2. Patient is not eligible for TAVR/SAVR .
3. Age ≥18 years.
4. Subjects who are willing to provide a written informed consent prior to participating in the study.
5. Subjects who can comply with the study follow up or other study requirements.
6. Subject eligible according to Clinical Review Committee
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Exclusion Criteria:
1. Subjects with any electrical device implanted.
2. Subjects with unstable arrhythmia not controlled by medical treatment.
3. Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position.
4. Subjects with complex congenital heart disease.
5. Chest deformity.
6. Cardiogenic shock.
7. History of heart transplant.
8. Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment.
9. Thrombus in heart.
10. Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one month prior to enrolment\*.
11. Subjects who are pregnant or nursing.
12. Subjects who are participating in another research study for which the primary endpoint has not been reached.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03779620
Study Brief:
Protocol Section:
NCT03779620