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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07317804
Eligibility Criteria:
Inclusion Criteria:
* 1\. Patients aged 70 years or older with obvious clinical symptoms or a left ventricular ejection fraction less than 50% due to severe aortic valve stenosis (aortic valve orifice area \< 1.0 cm² or peak velocity ≥ 4.0 m/s or mean transvalvular pressure ≥ 40 mmHg); or patients with obvious clinical symptoms of low blood flow and low pressure difference aortic valve stenosis (effective aortic valve orifice area \< 1.0 cm², mean transvalvular pressure difference \< 40 mmHg, left ventricular ejection fraction \< 50%, stroke volume index \< 35 ml/m², and diagnosed as true severe aortic valve stenosis by dobutamine stress test);
* 2\. Patients aged 65 years ≤ age \< 70 years with severe aortic stenosis who have surgical contraindications or high risks, or have other risk factors such as post-chest radiotherapy, liver failure, diffuse severe aortic calcification, extreme weakness, etc., or patients refuse to undergo routine open-chest surgery;
* 3\. The patient's anatomical structure is suitable for TAVR and can tolerate transesophageal ultrasound;
* 4\. The patient has signed the informed consent form and is willing to participate in this study.
Exclusion Criteria:
* 1\. Imaging (ultrasound and/or CT and/or MRI) confirmed a lesion, thrombus or calculus in the left ventricle;
* 2\. Severe obstruction of the left ventricular outflow tract;
* 3\. Severe right ventricular dysfunction;
* 4\. Acute myocardial infarction within 30 days before the surgery;
* 5\. Active endocarditis history within 180 days before the surgery;
* 6\. Inappropriate aortic root anatomy (such as combined aortic dissection, excessive aortic annulus, risk of coronary artery occlusion, etc.);
* 7\. Severe calcification and distortion of the surgical approach;
* 8\. Left ventricular ejection fraction less than 20%;
* 9\. Other cardiac diseases that require concurrent treatment (such as severe mitral regurgitation, atrial fibrillation, etc.);
* 10\. History of stroke or transient ischemic attack within 90 days before the surgery;
* 11\. Liver cirrhosis or active liver disease;
* 12\. Renal insufficiency (creatinine clearance rate \< 30 mL/min) and/or undergoing renal replacement therapy;
* 13\. Unable to tolerate anticoagulation therapy during or after the surgery;
* 14\. Participating in other drug or device research;
* 15\. Any emergency or surgical operation within 30 days before the surgery;
* 16\. Other severe comorbidities, even if the valve stenosis is corrected, the expected life expectancy is less than 1 year;
* 17\. Other conditions deemed unsuitable for TAVR surgery by the cardiac team.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT07317804
Study Brief:
Protocol Section:
NCT07317804