A Clinical Study Using FAPI-PET Imaging to Assess the Postoperative Effects of TAVI in Patients With 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

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.

Study Overview

• Status: Recruiting
• Conditions: Severe Aortic Valve Stenosis
• Intervention / Treatment: Procedure: Transcatheter Aortic Valve Implantation; Drug: Optimal medication treatment

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Pu, M.D.; Phone Number: 8613817577592; Email: pujun310@hotmail.com
• Study Contact Backup: Name: Peiliang Fang; Phone Number: 8618717992916; Email: 846943505@qq.com

Study Locations

• China
  • Shanghai, China, 201203
    • Recruiting
    • Renji Hospital,Shanghai
    • Contact: Jun Pu; Phone Number: 8613817577592; Email: pujun310@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAVI+OMT; Patients in the TAVI group will undergo transcatheter aortic valve implantation according to standard clinical procedures and receive optimal medical therapy.	Procedure: Transcatheter Aortic Valve Implantation; Patients in the TAVI group underwent transcatheter aortic valve implantation performed by the hospital's cardiac intervention team according to standard clinical procedures, and received optimal medical therapy（The recommended medications include: First category: SGLT2 inhibitors (gliflozin drugs) such as dapagliflozin and empagliflozin; Second category: Angiotensin receptor-neprilysin inhibitors (ARNI) with the representative drug sacubitril/valsartan; Third category: β-blockers (the '-lol' class) with representative drugs including bisoprolol, metoprolol sustained-release tablets, and carvedilol; Fourth category: Mineralocorticoid receptor antagonists (MRA, aldosterone receptor antagonists) with representative drugs spironolactone and eplerenone; Fifth category (for specific populations): vericiguat. Diuretics should be individualized, including loop diuretics such as furosemide and torasemide.）.; Drug: Optimal medication treatment; All enrolled patients must receive the Optimal medication treatment（The recommended medications include: First category: SGLT2 inhibitors (gliflozin drugs) such as dapagliflozin and empagliflozin; Second category: Angiotensin receptor-neprilysin inhibitors (ARNI) with the representative drug sacubitril/valsartan; Third category: β-blockers (the '-lol' class) with representative drugs including bisoprolol, metoprolol sustained-release tablets, and carvedilol; Fourth category: Mineralocorticoid receptor antagonists (MRA, aldosterone receptor antagonists) with representative drugs spironolactone and eplerenone; Fifth category (for specific populations): vericiguat. Diuretics should be individualized, including loop diuretics such as furosemide and torasemide.）.
Other: OMT; Optimal medication treatment	Drug: Optimal medication treatment; All enrolled patients must receive the Optimal medication treatment（The recommended medications include: First category: SGLT2 inhibitors (gliflozin drugs) such as dapagliflozin and empagliflozin; Second category: Angiotensin receptor-neprilysin inhibitors (ARNI) with the representative drug sacubitril/valsartan; Third category: β-blockers (the '-lol' class) with representative drugs including bisoprolol, metoprolol sustained-release tablets, and carvedilol; Fourth category: Mineralocorticoid receptor antagonists (MRA, aldosterone receptor antagonists) with representative drugs spironolactone and eplerenone; Fifth category (for specific populations): vericiguat. Diuretics should be individualized, including loop diuretics such as furosemide and torasemide.）.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FAPI-PET myocardial uptake value	All enrolled patients underwent a ^18F-FAPI-1801 PET/CT scan at baseline (before or at the time of TAVI) and at 6 months postoperatively to quantitatively assess the degree of myocardial fibroblast activation and structural remodeling indicators, with follow-up on clinical cardiac function changes. Patients with aortic stenosis who received only medical treatment were set as a control group for comparative analysis to evaluate the effect of relieving aortic stenosis on reducing myocardial fibrosis activity, as well as on myocardial remodeling and reversal of cardiac function.	Baseline and 6 months after enrollment

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Jun PU, RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 19, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: December 26, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Transcatheter Aortic Valve Replacement; Severe aortic valve stenosis; FAPI-PET
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Surgical Procedures, Operative; Cardiovascular Surgical Procedures; Cardiac Surgical Procedures; Thoracic Surgical Procedures; Prosthesis Implantation; Heart Valve Prosthesis Implantation; Transcatheter Aortic Valve Replacement
• Other Study ID Numbers: IIT-2025-0364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No