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OpenTrials
Completed

NCT Number: NCT05326126

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

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

Completed

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Raffaele

Milan, 20132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The burden of myocardial fibrosis

    Time frame: 1 year

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

  2. Index of microcirculatory resistance (IMR)

    Time frame: 1 year

    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.

Secondary outcomes

  1. Acute change in coronary flow reserve (CRF)

    Time frame: 1 year

    Ratio of maximal coronary blood flow obtained by hyperemia to baseline coronary blood flow

  2. Acute change in index of microcirculatory resistance (IMR)

    Time frame: 1 year

    Estimate of microvascular resistance derived by pressure and an indirect estimate of flow

  3. Computed tomography derived extracellular volume

    Time frame: 1 year

    The extracellular volume fraction (ECV) is the relative value of the volume of the extracellular space in the myocardium, therefore express as a percentage. It could be measured from computed tomography (CT) and Index of microcirculatory resistance (MRI) images, and was validated with histology. ECV-CT is calculated as follows:

    ECVCT = (1-haematocrit) × (ΔHUmyo/ΔHUblood) where ΔHU is the change in Hounsfield unit attenuation pre- and post-contrast (i.e. HUpost-contrast - HUpre-contrast)

  4. All-cause death

    Time frame: 1 year

    Death from any cause

  5. Cardiovascular death

    Time frame: 1 year

    Death from any cardiac condition (e.g. myocardial infarction, acute pulmonary edema, low-output state, etc..) or vascular condition (including aortic dissection, stroke, etc…)

  6. Any rehospitalization

    Time frame: 1 year

    Admission to an inpatients' service for any cause lasting >24h

  7. Cardiovascular rehospitalization

    Time frame: 1 year

    Admission to an inpatients' service for cardiovascular conditions lasting >24h

Sponsors and collaborators

Lead sponsor

Matteo Montorfano

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2022
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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