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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT03843320
Eligibility Criteria:
Inclusion Criteria:
* Severe native aortic valve stenosis symptomatic for heart failure or angina;
* Indication to isolated TAVR or SAVR given by heart team;
* TAVR through the trans-femoral approach;
* SAVR by any access;
* Implantation of an Edwards valve type (SAPIEN 3 and SAPIEN XT for TAVR; INSPIRIS RESILIA, EDWARDS INTUITY and Carpentier-Edwards PERIMOUNT Magna-Ease for SAVR);
* Signed informed consent.
Exclusion Criteria:
* Use of walking aids;
* Dyskinesia or Parkinson's disease;
* Reduced survival expectancy due to severe co-morbidities (\<1 year);
* Lack of any of inclusion criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
75 Years
Maximum Age:
89 Years
Study:
NCT03843320
Study Brief:
Protocol Section:
NCT03843320