FAPI-PET imaging to see heart tissue changes after TAVI for aortic stenosis

A Clinical Study Using FAPI-PET Imaging to Evaluate the Effects of TAVI on Reversing Myocardial Structural and Functional Remodeling in Patients With Aortic Stenosis

Using FAPI-PET scans, doctors will see if heart scarring and function improve after TAVI in people with severe aortic stenosis compared with those treated with medication alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07335900 on ClinicalTrials.gov

What this trial studies

Participants with severe degenerative aortic stenosis will be enrolled into two groups: those planned for transcatheter aortic valve implantation (TAVI) and a control group managed with medication only. All participants will receive a 18F-FAPI-1801 PET/CT scan at baseline (before or at the time of TAVI) and again at six months to measure myocardial fibroblast activation and indicators of structural remodeling. Clinical cardiac function will be followed alongside imaging to relate changes in fibrosis activity to functional recovery. Comparative analysis will determine whether relieving aortic stenosis with TAVI is associated with reduced fibroblast activity and reversal of remodeling versus medical therapy alone.

Who should consider this trial

Good fit: Adults (age ≥18) with confirmed severe degenerative aortic stenosis who are judged by the heart team to be unsuitable for surgical valve replacement and who either plan to undergo TAVI or opt for medical therapy.

Not a fit: Patients with recent acute myocardial infarction, those unable to undergo PET/CT, or patients proceeding to surgical valve replacement instead of TAVI are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could show whether TAVI reduces myocardial fibrotic activity and promotes reverse remodeling, helping guide treatment timing and patient selection.

How similar studies have performed: Early clinical work has used FAPI-PET to detect myocardial fibroblast activation in various cardiac conditions, but using it specifically to track changes after TAVI is relatively novel and not yet widely validated.

Eligibility criteria

Inclusion Criteria:

① Age 18 years or older, any gender; ② Confirmed diagnosis of severe degenerative aortic stenosis by echocardiography (valve area AVA \< 1.0 cm² or mean transvalvular gradient \> 40 mmHg; for AS with reduced ejection fraction and low-flow, low-gradient, the presence of outflow tract reserve must be confirmed with dobutamine stress); ③ Evaluated by the 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 transcatheter valve implantation. Patients who meet these criteria and decide to undergo TAVI will be assigned to the TAVI group; those who meet the criteria but do not undergo valve replacement will enter the control group (possible scenarios include: relatively mild valve stenosis not meeting TAVI indication, or patient refusal of surgery, opting for drug therapy only, etc.).

Exclusion Criteria:

* Recent acute myocardial infarction (less than 1 month from onset to enrollment) or the presence of active myocarditis, infectious endocarditis, and other acute inflammatory conditions, as these conditions can significantly affect FAPI uptake and cardiac function; ② History of old myocardial infarction (with existing myocardial scarring and remodeling, which affect fibroblast imaging); ③ Presence of uncontrolled severe arrhythmias, such as persistent ventricular tachycardia, ventricular fibrillation, or high-risk second-degree or higher atrioventricular block, resulting in hemodynamic instability due to arrhythmia within the past 3 months; ④ Concomitant severe cardiovascular diseases affecting study evaluation, including severe valvular disease (excluding AS, such as severe mitral regurgitation), hypertrophic obstructive cardiomyopathy, primary pulmonary hypertension, etc.; ⑤ Presence of examination contraindications: allergy to PET tracers or MRI contrast agents, severe renal insufficiency (eGFR \<30 ml/min/1.73 m²) with inability to tolerate gadolinium-enhanced MRI, or severe claustrophobia preventing compliance with imaging examinations; ⑥ Allergic constitution (history of allergy to multiple drugs or unknown substances); ⑦ Pregnant or breastfeeding women (female subjects of childbearing potential must provide a negative pregnancy test before enrollment and use effective contraception during the study); ⑧ Any other situation that the investigator believes could significantly increase study risk or interfere with result interpretation, such as active malignant tumors or advanced disease with expected survival of less than 1 year; ⑨ Inability to comply with the trial protocol or follow-up requirements (e.g., poor prior adherence, expected inability to attend scheduled follow-ups).

Where this trial is running

Shanghai

• Renji Hospital,Shanghai — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Jun PU — RenJi Hospital
• Study coordinator: Jun Pu, M.D.

Conditions Severe Aortic Valve Stenosis; Severe aortic valve stenosis; Transcatheter Aortic Valve Replacement; FAPI-PET