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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05326126
Other study ID # TAVI IMR
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 8, 2021
Est. completion date October 30, 2025

Study information

Verified date March 2024
Source IRCCS San Raffaele
Contact Marco Ancona, MD
Phone +39/26437331
Email ancona.marco@hsr.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date October 30, 2025
Est. primary completion date October 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Italy IRCCS San Raffaele Milan

Sponsors (1)

Lead Sponsor Collaborator
Matteo Montorfano

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary The burden of myocardial fibrosis Myocardial fibrosis measured as the percentage of delay-enhanced myocardium over total myocardial volume 1 year
Primary 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 Acute change in coronary flow reserve (CRF) Ratio of maximal coronary blood flow obtained by hyperemia to baseline coronary blood flow 1 year
Secondary Acute change in index of microcirculatory resistance (IMR) Estimate of microvascular resistance derived by pressure and an indirect estimate of flow 1 year
Secondary 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) × (?HUmyo/?HUblood) where ?HU is the change in Hounsfield unit attenuation pre- and post-contrast (i.e. HUpost-contrast - HUpre-contrast)
1 year
Secondary All-cause death Death from any cause 1 year
Secondary 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…) 1 year
Secondary Any rehospitalization Admission to an inpatients' service for any cause lasting >24h 1 year
Secondary Cardiovascular rehospitalization Admission to an inpatients' service for cardiovascular conditions lasting >24h 1 year
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02210351 - Evaluation of Association Between Apical Dysfunction and Trans Apical Access for TAVR, in Patients With Severe Aortic Stenosis, Undergoing Trans Apical Trans Catheter Aortic Valve Replacement (TAP-TAVR). N/A
Completed NCT02956915 - Evaluation of Length of Stay After TF-TAVI
Completed NCT04663334 - Change in Coronary Microcirculation and FFR After TAVI in Patients With Cardiovascular Comorbidities
Withdrawn NCT01742598 - Assessment of St Jude Medical Portico Re-sheathable Transapical Aortic Valve System N/A
Withdrawn NCT01927601 - Assessment of Neurologic Injury Subsequent to Transcatheter Aortic Valve Replacement: A Feasibility Study N/A
Completed NCT01787084 - Alternative Access Approaches for Transcatheter Aortic Valve Replace (TAVR) in Inoperable Patients With Aortic Stenosis N/A