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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT05261204
Eligibility Criteria:
Inclusion Criteria:
* Individuals enrolled in TAVI arm were required to have the predicted risk of operative mortality was ≥ 15% and/or a STS score of ≥ 10. A candidate who did not meet the STS score criteria of ≥ 10 was included in the study if a peer review by at least two surgeon investigators concluded and documented that the patient's predicted risk of operative mortality was ≥ 15%. For all group Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient \> 40 mm Hg or jet velocity \> 4.0 m/s or an aortic valve area (AVA) of \< 0.8 cm2 (or AVA index \< 0.5 cm2/m2).
Exclusion Criteria:
* • Patients with evidence of an acute myocardial infarction ≤ 1 month before the intended treatment (defined as Q wave MI, or non-Q wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin level elevation.
* Blood dyscrasias as defined : leukopenia (WBC \< 3000 mm3), acute anemia (Hb \< 9 mg%), thrombocytopenia (platelet count \< 50,000 cells/mm³), history of bleeding diathesis or coagulopathy.
* Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices
* Need for emergency surgery for any reason.
* Hypertrophic cardiomyopathy with or without obstruction.
* Severe ventricular dysfunction with LVEF \< 20%.
* Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
* Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months.
* A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel
* (Plavix), or sensitivity to contrast media, which cannot be adequately pre-medicated.
* For TAVI arm Native aortic annulus size \< 18mm or 25mm as measured by echocardiogram.
* Subject was offered surgery but refused surgery.
* Recent (within 6 months) cerebrovascular accident or transient ischemic attack.
* Renal insufficiency (creatinine \> 3.0mg/dL) and/or end stage renal disease requiring chronic
* dialysis.
* Life expectancy \< 12 months due to non-cardiac co-morbid conditions.
* For TAVI group significant abdominal or thoracic aorta disease, including aneurysm (defined as maximal luminal diameter 5 cm or greater), marked tortuosity, aortic arch atheroma, narrowing of the abdominal aorta with particular regard for calcification and surface irregularities, or severe "unfolding" and tortuosity of the thoracic aorta. This criteria were applicable for transfemoral patients only.
* For TAVI group Iliofemoral vessel characteristics that would preclude safe placement of 14F or 18F introducer
* For TAVI arm sheath such as severe calcification, severe tortuosity or vessels size diameter \< 7 mm for 22F
* Active bacterial endocarditis or other active infections.
* For TAVI arm bulky calcified aortic valve leaflets in close proximity to coronary ostia.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT05261204
Study Brief:
Protocol Section:
NCT05261204