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

NCT05326126 | Completed DMC

• 1 other identifier: TAVI IMR
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Severe Symptomatic Aortic Stenosis

Outcome Measures

Primary Outcomes (2)

• The burden of myocardial fibrosis

  Myocardial fibrosis measured as the percentage of delay-enhanced myocardium over total myocardial volume

  1 year

• Index of microcirculatory resistance (IMR)

  IMR a validated estimate of resistance in the coronary capillary, computed as the ratio between transit time of a 3 cc bolus of room temperature saline and distal coronary artery pressure.

  1 year

Secondary Outcomes (7)

• Acute change in coronary flow reserve (CRF)

  1 year

• Acute change in index of microcirculatory resistance (IMR)

  1 year

• Computed tomography derived extracellular volume

  1 year

• All-cause death

  1 year

• Cardiovascular death

  1 year

Study Arms (1)

Coronary physiology evaluation

EXPERIMENTAL

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.

Device: coronary physiology

Interventions

coronary physiology DEVICE

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

Coronary physiology evaluation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Matteo Montorfano: lead

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

Location

Study Officials

• Matteo montorfano, MD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients will be assigned a univocal identification code. Medical personnel in charge of baseline, in-hospital and follow-up data acquisition will be allowed to know each patient identity.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Interventional cardiologist

Model Details: TAVI's intervention will be performed as per current clinical indications and according to the hospital's clinical practice. To this will be added the evaluation of coronary physiology using Pressure Eire X and Coroventis software, which, although performed in accordance with the IFU of the aforementioned devices, is considered an experimental procedure. Adenosine will be required to complete the measurement of coronary physiology

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: April 13, 2022
• Study Start: July 8, 2021
• Primary Completion: June 30, 2025
• Study Completion: July 30, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)