Clinical trial NCT05326126: Microvascular Function in Patients Undergoing Transcatheter Aortic Valve Implant (TAVI) for Severe Symptomatic Aortic Stenosis: Association With Myocardial Fibrosis
Official title: Microvascular Function in Patients Undergoing Transcatheter Aortic Valve Implant (TAVI) for Severe Symptomatic Aortic Stenosis: Association With Myocardial Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Symptomatic Aortic Stenosis
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: The burden of myocardial fibrosis
timeFrame: 1 year
measure: Index of microcirculatory resistance (IMR)
timeFrame: 1 year
Secondary outcomes:
measure: Acute change in coronary flow reserve (CRF)
timeFrame: 1 year
measure: Acute change in index of microcirculatory resistance (IMR)
timeFrame: 1 year
measure: Computed tomography derived extracellular volume
timeFrame: 1 year
measure: All-cause death
timeFrame: 1 year
measure: Cardiovascular death
timeFrame: 1 year
measure: Any rehospitalization
timeFrame: 1 year
measure: Cardiovascular rehospitalization
timeFrame: 1 year
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele
Study officials:
affiliation: IRCCS San Raffaele
name: Matteo montorfano, MD
role: PRINCIPAL_INVESTIGATOR
References: