Microvascular Function in Patients Undergoing Transcatheter Aortic Valve Implant (TAVI) for Severe Symptomatic Aortic Stenosis: Association With Myocardial Fibrosis

NCT ID: NCT05326126

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-08
• Study Completion Date: 2025-09-10

Brief Summary

Microvascular function in patients undergoing Transcatheter Aortic Valve Implant (TAVI) for severe symptomatic aortic stenosis: association with myocardial fibrosis

Detailed Description

Severe symptomatic aortic stenosis is commonly encountered in clinical practice, affecting close to 5% of individuals older than 65 years of age, and carries a dismal prognosis if left untreated.(1,2) Chronically increased left ventricular afterload triggers a compensatory myocardial response, ultimately leading to ventricular hypertrophy, aimed at reducing chronically increased wall tension an restore cardiac performance.(3) Hypertrophy ultimately results in maladaptive changes and ultimately leads to heart failure and eventually increased risk of cardiac mortality. Myocardial fibrosis and altered myocardial perfusion appear to play a role in progressive cardiac decompensation.

Conditions

Severe Symptomatic Aortic Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Coronary physiology evaluation

Patient will undergo TAVI and then Myocardial fibrosis will be evaluated on images acquired at the time of the cardiac CT obtained for TAVI planning. Briefly, an extra late post-contrast acquisition image will be acquired. The delayed post-contrast scan will be reconstructed with a soft convolution kernel and will be reformatted in the short- and long-axis planes (slice thickness 8 mm; gap 0 mm) in average mode.

Group Type: EXPERIMENTAL

coronary physiology

Intervention Type: DEVICE

To evaluate the association between microvascular disfunction and myocardial fibrosis identified per computed tomography among subjects undergoing TAVI for severe, symptomatic aortic stenosis.

Interventions

coronary physiology

To evaluate the association between microvascular disfunction and myocardial fibrosis identified per computed tomography among subjects undergoing TAVI for severe, symptomatic aortic stenosis.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All patients referred to IRCCS Ospedale San Raffaele who are candidates to receive a TAVI implant for severe, symptomatic aortic stenosis under current appropriateness criteria and clinical practice guidelines will be considered eligible to take part in the study

Exclusion Criteria

• Age <18 years
• Inability to express informed consent to take part in the present study.
• Pregnancy or lactation
• Pre-existing known disease determining a prognosis quo ad vitam shorter than the follow up of the present study
• Significant chronic kidney disease (estimated glomerular filtration rate <30 ml/min)
• Known significant epicardial coronary artery stenosis
• Known contraindication to adenosine administration:
• Known allergic reactions
• Second or third degree atrioventricular block before the procedure (in absence of a functional permanent pacemaker)
• Long QT syndrome
• Unstable angina
• Severe hypotension
• Acutely decompensated heart failure
• Chronic obstructive pulmonary disease with bronchospasm
• Concomitant use of dypiridamole

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Matteo Montorfano

OTHER

Sponsor Role: lead

Responsible Party

Matteo Montorfano

Interventional cardiologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Matteo montorfano, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Raffaele

Locations

IRCCS San Raffaele

Milan, Italy, Italy

Countries

Italy

Other Identifiers

TAVI IMR

Identifier Type: -

Identifier Source: org_study_id