Actively Recruiting
A Clinical Study Using FAPI-PET Imaging to Assess the Postoperative Effects of TAVI in Patients With Aortic Stenosis
Led by RenJi Hospital · Updated on 2026-01-13
25
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will include patients with severe degenerative aortic stenosis (AS) who meet the inclusion criteria and voluntarily participate (planned to undergo TAVI), as well as patients with aortic stenosis who have not undergone valve replacement (control group). All enrolled patients will undergo a \^18F-FAPI-1801 PET/CT scan at baseline (before or at the time of TAVI) and 6 months postoperatively to quantitatively evaluate myocardial fibroblast activation and structural remodeling indicators, and to follow up on changes in clinical cardiac function. Patients with aortic stenosis receiving only medical therapy will be set as the control group for comparative analysis, to assess the impact of relieving aortic stenosis on the reduction of myocardial fibrosis activity, myocardial remodeling, and reversal of cardiac function.
CONDITIONS
Official Title
A Clinical Study Using FAPI-PET Imaging to Assess the Postoperative Effects of TAVI in Patients With Aortic Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Confirmed diagnosis of severe degenerative aortic stenosis by echocardiography (valve area AVA < 1.0 cm6 or mean transvalvular gradient > 40 mmHg; for AS with reduced ejection fraction and low-flow, low-gradient, must confirm outflow tract reserve with dobutamine stress)
- Evaluated by heart team as unsuitable for surgical open-heart valve replacement due to advanced age or severe comorbidities, without anatomical contraindications, and expected to benefit from TAVI
- Patients who decide to undergo TAVI will be assigned to the TAVI group; those who do not undergo valve replacement will enter the control group
You will not qualify if you...
- Recent acute myocardial infarction (less than 1 month from onset to enrollment)
- Active myocarditis, infectious endocarditis, or other acute inflammatory conditions
- History of old myocardial infarction with existing myocardial scarring and remodeling
- Uncontrolled severe arrhythmias causing hemodynamic instability within the past 3 months
- Severe cardiovascular diseases affecting study evaluation, including severe mitral regurgitation, hypertrophic obstructive cardiomyopathy, primary pulmonary hypertension
- Allergy to PET tracers or MRI contrast agents, severe renal insufficiency (eGFR <30 ml/min/1.73 m6), or severe claustrophobia preventing imaging
- History of multiple drug or unknown substance allergies
- Pregnant or breastfeeding women; females of childbearing potential must have a negative pregnancy test and use effective contraception during the study
- Any condition judged by the investigator to increase study risk or interfere with results, such as active malignant tumors or life expectancy less than 1 year
- Inability to comply with trial protocol or follow-up requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Renji Hospital,Shanghai
Shanghai, China, 201203
Actively Recruiting
Research Team
J
Jun Pu, M.D.
CONTACT
P
Peiliang Fang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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