Severe Symptomatic Aortic StenosisNCT05326126
Microvascular Function in Patients Undergoing Transcatheter Aortic Valve Implant (TAVI) for Severe Symptomatic Aortic Stenosis: Association With Myocardial Fibrosis
A study testing coronary physiology in people with Severe Symptomatic Aortic Stenosis, run by Matteo Montorfano at 1 site in Italy.
Trial summary
Microvascular function in patients undergoing Transcatheter Aortic Valve Implant (TAVI) for severe symptomatic aortic stenosis: association with myocardial fibrosis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Symptomatic Aortic Stenosis
- What is being tested?
- coronary physiology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jul 2021to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Microvascular function in patients undergoing Transcatheter Aortic Valve Implant (TAVI) for severe symptomatic aortic stenosis: association with myocardial fibrosis
Read the 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.
- Conditions
- Severe Symptomatic Aortic Stenosis
- Being tested
- coronary physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary physiologyDevice
To evaluate the association between microvascular disfunction and myocardial fibrosis identified per computed tomography among subjects undergoing TAVI for severe, symptomatic aortic stenosis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: coronary physiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
The burden of myocardial fibrosis
Myocardial fibrosis measured as the percentage of delay-enhanced myocardium over total myocardial volume
Measured: 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.
Measured: 1 year
Secondary outcomes (7)
Acute change in coronary flow reserve (CRF)
Ratio of maximal coronary blood flow obtained by hyperemia to baseline coronary blood flow
Measured: 1 year
Acute change in index of microcirculatory resistance (IMR)
Estimate of microvascular resistance derived by pressure and an indirect estimate of flow
Measured: 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)
Measured: 1 year
All-cause death
Death from any cause
Measured: 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…)
Measured: 1 year
Any rehospitalization
Admission to an inpatients' service for any cause lasting >24h
Measured: 1 year
Cardiovascular rehospitalization
Admission to an inpatients' service for cardiovascular conditions lasting >24h
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start8 Jul 2021
- Primary completion30 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Symptomatic Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matteo Montorfano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matteo Montorfano, IRCCS San Raffaele
- Investigators
- Matteo montorfano, MD, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326126
- Sponsor's protocol ID
- TAVI IMR
- Status last verified
- Mar 2026
- First submitted
- 8 Oct 2021
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Function in Patients Undergoing Transcatheter Aortic Valve Implant (TAVI) for Severe Symptomatic Aortic Stenosis: Association With Myocardial Fibrosis
- ClinicalTrials.gov ID
- NCT05326126
- Acronym / sponsor ID
- TAVI IMR
- Conditions
- Severe Symptomatic Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Matteo MontorfanoUniversity, hospital or other
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Coronary physiology evaluation | Experimental | Device: coronary physiologyPatient 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary physiologyTo evaluate the association between microvascular disfunction and myocardial fibrosis identified per computed tomography among subjects undergoing TAVI for severe, symptomatic aortic stenosis. | Device | Coronary physiology evaluation |
Primary outcome
The burden of myocardial fibrosis
Time frame: 1 year
Myocardial fibrosis measured as the percentage of delay-enhanced myocardium over total myocardial volume
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.
7 secondary outcomes
Acute change in coronary flow reserve (CRF)
Time frame: 1 year
Acute change in index of microcirculatory resistance (IMR)
Time frame: 1 year
Computed tomography derived extracellular volume
Time frame: 1 year
All-cause death
Time frame: 1 year
Cardiovascular death
Time frame: 1 year
Any rehospitalization
Time frame: 1 year
Cardiovascular rehospitalization
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Severe Symptomatic Aortic Stenosis
RecruitingObservational study
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Active, not recruiting
DurAVR™ THV EU-EFS
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
Active, not recruiting
Portico Next Generation Approval Study
Symptomatic Severe Aortic Stenosis
Not yet recruiting
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
Active, not recruiting
DurAVR™ THV System: EMBARK Study
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matteo montorfano, MD principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coronary physiology in people with Severe Symptomatic Aortic Stenosis, run by Matteo Montorfano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The burden of myocardial fibrosis (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.