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:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT02472106
Eligibility Criteria:
Inclusion Criteria:
* Subjects with severe symptomatic aortic stenosis (AS) indicated and scheduled for a transcatheter aortic valve implant (TAVI) with the Medtronic CoreValve or another self-expanding TAVI device.
* The TAVI device size is determined preoperatively with CTA according to standard guidelines. Patients may undergo transfemoral, subclavian, or transaortic approach.
* Balloon postdilatation (BPD) is carried out after CoreValve or other self-expanding TAVI device implantation if, based on operator's judgment, BPD is indicated because of presence of paravalvular leak (PVL).
* Hemodynamically stable for 3 - 10 minutes after the TAVI procedure.
* Probable survival to hospital discharge.
* Subject is competent, willing to comply with evaluations, understands risks, benefits and alternatives and has signed the Informed Consent Form.
Exclusion Criteria:
* Cardiogenic shock, as defined by a consistent systolic blood pressure \<80 mmHg off vasopressors or \<90 mmHg on vasopressors.
* PVL occurring secondary to excessively high or low valve positioning.
* Trauma or significant structural damage to underlying native tissue calls for emergent intervention or threatens long-term outcome prior to the BPD.
* Patients receiving two valves (i.e. aortic THV valve in valve).
* Patients with AS secondary to congenital valve disease including bicuspid aortic valve.
* PVL occurring due to TAVI device under sizing. Example of determining the undersizing is to calculate the Cover Index which represents the percent of over sizing of the nominal transcatheter heart valve (THV) area compared to the measured native valve annulus area. Under sizing is defined as TAVI screening CTA with a pre procedure cover index by area of \<5%.
* Vulnerable subjects and any subjects incapable of giving consent, including patients with incurable diseases, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and subjects with cognitive impairment, such as persons with a mental illness or dementia.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02472106
Study Brief:
Protocol Section:
NCT02472106