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:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT03143361
Eligibility Criteria:
Inclusion criteria
* Age \>18 yy
* Isolated SAVS with or without concomitant aortic valve regurgitation
* Isolated prosthetic aortic dysfunction
* SAVS + coronary artery disease (CAD)
* Prosthetic aortic dysfunction + CAD
* Elective, urgent and emergent procedures
* Endocarditic aetiology
Exclusion criteria
* Patients undergoing concomitant mitral valve surgery, or tricuspid valve surgery, or aortic surgery (i.e. composite aortic valve and ascending aorta replacement with or without circulatory arrest), or atrial fibrillation surgery, or any other associated cardiac surgical procedure (with the exception of CABG)
* Concomitant aortic root procedure (i.e. Bentall operation, David operation, homografts, autografts)
* SAVR with techniques of aortic annular enlargement
* Porcelain aorta
* Pure aortic valve regurgitation
* Percutaneous TAVR requiring surgical cut-down (i.e. failure to comply with a full percutaneous approach, thus configuring a "hybrid procedure")
* Patient refusal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03143361
Study Brief:
Protocol Section:
NCT03143361