An interventional study of coronary physiology in Severe Symptomatic Aortic Stenosis, sponsored by Matteo Montorfano. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Matteo Montorfano · Not applicable, Interventional, and Other
Microvascular function in patients undergoing Transcatheter Aortic Valve Implant (TAVI) for severe symptomatic aortic stenosis: association with myocardial fibrosis
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.
This is the only study on the registry with Matteo Montorfano as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
To evaluate the association between microvascular disfunction and myocardial fibrosis identified per computed tomography among subjects undergoing TAVI for severe, symptomatic aortic stenosis.
The burden of myocardial fibrosis
Myocardial fibrosis measured as the percentage of delay-enhanced myocardium over total myocardial volume
Time frame: 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.
Time frame: 1 year
Acute change in coronary flow reserve (CRF)
Ratio of maximal coronary blood flow obtained by hyperemia to baseline coronary blood flow
Time frame: 1 year
Acute change in index of microcirculatory resistance (IMR)
Estimate of microvascular resistance derived by pressure and an indirect estimate of flow
Time frame: 1 year
Computed tomography derived extracellular volume
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)
Time frame: 1 year
All-cause death
Death from any cause
Time frame: 1 year
Cardiovascular death
Death from any cardiac condition (e.g. myocardial infarction, acute pulmonary edema, low-output state, etc..) or vascular condition (including aortic dissection, stroke, etc…)
Time frame: 1 year
Any rehospitalization
Admission to an inpatients' service for any cause lasting \>24h
Time frame: 1 year
Cardiovascular rehospitalization
Admission to an inpatients' service for cardiovascular conditions lasting \>24h
Time frame: 1 year
Plan to share: No
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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