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 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT05374733
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18.
* a) TAVI cohort: severe aortic valve stenosis for which TAVI is scheduled after discussion in the Heart Team.
b) TMVr cohort: severe functional/degenerative mitral regurgitation for which TMVr is scheduled after discussion in the Heart Team.
* At least intermediate coronary artery disease, defined as 50-99% diameter stenosis in a vessel ≥ 2.5 mm
* Elective procedure
* Written informed consent
Exclusion Criteria:
* TAVI cohort: height coronary ostia \< 10 mm
* Severe chronic kidney disease, defined as estimated glomerular filtration rate \< 30 ml/min.
* Contra-indication for intravenous adenosine: severe asthma or chronic obstructive pulmonary disease, known allergy to adenosine or previous reported bronchospasm in response to adenosine.
* Degenerated surgical or transcatheter aortic valve bioprosthesis.
* Vessels that have collaterals to a chronic total occlusion or that are supplied by an arterial or venous bypass graft will not be interrogated in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05374733
Study Brief:
Protocol Section:
NCT05374733