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 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT02803294
Eligibility Criteria:
Inclusion Criteria:
* Patients with symptomatic aortic stenosis/regurgitation
* Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
* The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
* Patients are technical and anatomical eligible for interventions
Exclusion Criteria:
* A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: Aspirin Heparin (HIT/HITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine and clopidogrel Contrast media
* Subject refuses a blood transfusion.
* Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
* Life expectancy is less than one year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02803294
Study Brief:
Protocol Section:
NCT02803294