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

NCT07335900 | Recruiting

• 1 other identifier: IIT-2025-0364
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Aortic Valve Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

TAVI+OMT

EXPERIMENTAL

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; Drug: Optimal medication treatment

OMT

OTHER

Optimal medication treatment

Drug: Optimal medication treatment

Interventions

Transcatheter Aortic Valve Implantation PROCEDURE

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.）.

TAVI+OMT

Optimal medication treatment DRUG

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.）.

OMT; TAVI+OMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.).

You may not qualify if:

• 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).

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital,Shanghai

Shanghai, 201203, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Jun PU

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Pu, M.D.

CONTACT

8613817577592; pujun310@hotmail.com

Peiliang Fang

CONTACT

8618717992916; 846943505@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 13, 2026
• Study Start: December 19, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

CN (1)