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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT03424902
Eligibility Criteria:
Inclusion Criteria:
* The following will be eligible for TAVI :
1. Intermediate or high risk patient for surgical aortic valve replacement (SAVR) STS/EuroSCORE II \>4% or logistic EuroSCORE I \>10%(10).
2. Contraindications for open chest surgery, such as(10) :
1. Expected high perioperative risk due to comorbidities not adequately reflected by scores :
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1. Procelain aorta
2. Squelae of chest radiation.
3. Severe chest deformation or scoliosis.
4. Previous cardiac surgery .
Exclusion Criteria:
* A-clinical conditions.
1. active endocarditis,
2. myocardial infarction within 14 days
3. cardiogenic shock
4. Life expectancy of less than 1 year
B-Anatomical conditions:
1. short distance between coronary ostia and aortic valve annulus.
2. Size of aortic annulus out of range for TAVI(range from 18mm - 27mm)(10).
C-Associated cardiac condition requiring concomitant intervention eg severe CAD require CABG ,aneurysm of ascending aorta ,severe mitral or tricuspid valve disease.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03424902
Study Brief:
Protocol Section:
NCT03424902