Heart valve fix: why some patients still have trouble?
NCT ID NCT05326126
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study examined how tiny blood vessels in the heart work after a TAVI procedure, which replaces a narrowed heart valve without open surgery. Researchers measured blood flow and scarring in the heart muscle of 75 patients. The goal was to see if poor small-vessel function is linked to heart muscle damage, which could explain why some people still feel symptoms after valve replacement.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors better understand why some patients still have heart problems after TAVI, pointing toward new ways to treat or prevent those issues.
- What could go wrong
- This was a small, observational study that only measured outcomes without testing a new treatment. The findings may not apply to all TAVI patients and need further research to confirm.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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75 people
The number who actually took part.
- Started
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Jul 2021
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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IRCCS San Raffaele
Milan, 20132, Italy
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