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Microvascular Function in Patients Undergoing Transcatheter Aortic Valve Implant (TAVI) for Severe Symptomatic Aortic Stenosis: Association With Myocardial Fibrosis

Launched by MATTEO MONTORFANO · Apr 8, 2022

Trial Information

Current as of June 17, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how well blood vessels function in patients who are getting a special heart procedure called Transcatheter Aortic Valve Implantation (TAVI) for severe aortic stenosis, which is a condition that narrows the heart's main valve. The researchers want to see if there's a connection between how these small blood vessels work and a heart condition called myocardial fibrosis, where heart tissue becomes stiff and less effective.

To participate in this study, you need to be between 65 and 75 years old and have been referred for the TAVI procedure due to severe aortic stenosis. However, there are some conditions that might prevent someone from joining, like being under 18, having severe kidney issues, or certain heart problems. If you take part, you can expect to help researchers learn more about heart health and how it relates to this procedure, which could ultimately benefit future patients. This trial is currently recruiting participants, so if you think you might be eligible, it’s worth discussing with your healthcare team.

Gender

ALL

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

About Matteo Montorfano

Matteo Montorfano is a dedicated clinical trial sponsor with a focus on advancing medical research and innovation. With a commitment to improving patient outcomes, Montorfano oversees the design, implementation, and management of clinical trials across various therapeutic areas. His expertise in regulatory compliance, data integrity, and collaboration with multidisciplinary teams ensures that each trial adheres to the highest ethical standards and scientific rigor. By fostering partnerships with healthcare institutions and leveraging cutting-edge technologies, Matteo Montorfano aims to accelerate the development of new treatments and enhance the overall quality of care.

Locations

Milan, , Italy

Patients applied

0 patients applied

Trial Officials

Matteo montorfano, MD

Principal Investigator

IRCCS San Raffaele

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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