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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.).

Locations
Other Locations
China
Renji Hospital,Shanghai
RECRUITING
Shanghai
Contact Information
Primary
Jun Pu, M.D.
pujun310@hotmail.com
8613817577592
Backup
Peiliang Fang
846943505@qq.com
8618717992916
Time Frame
Start Date: 2025-12-19
Estimated Completion Date: 2027-05-30
Participants
Target number of participants: 25
Treatments
Experimental: TAVI+OMT
Patients in the TAVI group will undergo transcatheter aortic valve implantation according to standard clinical procedures and receive optimal medical therapy.
Other: OMT
Optimal medication treatment
Sponsors
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov