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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT04581694
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic patients with severe aortic valve stenosis (AoS).
* CKD in stage ≥3a (GFR \<60mL / min / 1.73m2).
* Signature of the free and informed consent form (ICF).
Exclusion Criteria:
\- Any condition considered a contraindication for the implantation of a biological valve prosthesis (for example, the patient has an indication for mechanical valve prosthesis).
• Hypersensitivity or known contraindication to any of the following items that cannot be adequately premedicated: aspirin, clopidogrel or heparin (HIT / HITTS) nitinol (titanium or nickel) the contrast medium (pilot phase)
* Blood dyscrasias: leukopenia (white blood cell count \<1000 / mm3), thrombocytopenia (platelet count \<50,000 cells / mm3), history of hemorrhagic diathesis, coagulopathy or hypercoagulable states.
* Active infection, including active endocarditis.
* Cardiogenic shock manifested by low cardiac output, dependence on vasopressors or mechanical hemodynamic support.
* Recent stroke (up to 2 months after heart-team evaluation) or transient ischemic attack.
* Gastrointestinal bleeding that prevents platelet anticoagulation or anti-aggregation.
* Refusal to transfuse blood.
* Severe dementia (resulting in the inability to provide informed consent for the study / procedure).
* Life expectancy estimated at less than 12 months.
* Other medical, social or psychological conditions that, in the investigator's opinion, prevent the patient from consenting or adhering adequately to the protocol.
* Pre-existing prosthetic heart valve in the aortic position.
* Presence of stenosis or significant mitral regurgitation.
* Presence of obstructive hypertrophic cardiomyopathy.
* Clinical indication for coronary angiography or percutaneous coronary intervention in the period including the previous 30 days and 30 days after the TAVI procedure. In this case, the use of contrast media for these procedures can be a confusing factor for the analysis of the primary study outcome.
* Contraindication for the transfemoral approach based on evaluation by non-contrast TCMS and by CO2 aortoiliac angiography (anatomical screening).
* High risk of rupture of the ring or significant residual paravalvular leak due to important calcification of the left ventricular outflow tract.
* High risk of coronary occlusion (height of the coronary ostium \<10 mm with narrow SOV: \<1 mm greater than the size of the bioprosthesis) defined by imaging methods.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04581694
Study Brief:
Protocol Section:
NCT04581694