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 @ 1:40 PM
Ignite Modification Date:
2025-12-24 @ 1:40 PM
NCT ID:
NCT04632095
Eligibility Criteria:
Inclusion Criteria:
* Indication for elective isolated aortic valve replacement
* Anatomical suitability for both sternotomy and parasternal access
* Age ≥ 18
* Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
Exclusion Criteria:
* Planned simultaneous cardiac surgery interventions (Mitral valve surgery, tricuspid valve surgery, CABG, Pacemaker or defibrillator implantation, Pulmonalvenenisolation, Maze, closure of left atrial appendage , patent foramen ovale or atrial septal defect closure)
* Acute myocardial infarction within 4 weeks, coronary heart disease
* Acute endocarditis
* TIA or stroke within 6 months prior to the procedure
* Pregnant or breast-feeding women
* Renal failure requiring dialysis
* Ejection fraction ≤ 30%
* Re-operation
* Disease with a life expectancy \< 2 years
* Therapy with glucocorticoids or immunosuppressants
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04632095
Study Brief:
Protocol Section:
NCT04632095