Trials
Search / Trial NCT05637983

Ultrasound-guided Femoral Puncture to Reduce Access- Related Complications After TAVR: (ACCESS-TAVR SIRIO)

Launched by FONDAZIONE TOSCANA GABRIELE MONASTERIO · Nov 25, 2022

Trial Information

Current as of February 05, 2025

Unknown status

Keywords

ClinConnect Summary

Transfemoral approach has become the standard route for a transcatheter aortic valve replacement (TAVR) procedure. Despite the technology improvements, vascular complications and access-related bleeding are frequently observed after TAVR and emerge predominantly within 30 days after TAVR. Recent observational data showed a marked reduction of vascular and bleeding complications by the use of ultrasound(US)- guided femoral artery puncture to gain the vascular access and guide the implantation of the Perclose ProGlide® vascular closure system.

We aimed to compare in a 1:1 randomized fashion ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Eligible Patients are male or female with severe aortic stenosis evaluated by the Heart Team as candidate to TAVR based on the current cardiology guidelines.
  • Exclusion Criteria:
  • Refusal to participate in the study;
  • Inability to provide written consent to the study protocol;
  • Chronic immuno-suppressant therapy;
  • Any concomitant condition which, in the opinion of the Investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional/psychological disorder);
  • Enrolment in another study that could confound the results of this study;
  • Life expectancy \< 1 year;
  • Any contraindication to TAVR procedure;
  • Non transfemoral TAVR.

Trial Officials

Sergio Berti, MD

Principal Investigator

Fondazione Toscana Gabriele Monasterio

Eliano Navarese

Principal Investigator

Nicolaus Copernicus University

About Fondazione Toscana Gabriele Monasterio

Fondazione Toscana Gabriele Monasterio is a leading research institution based in Tuscany, Italy, dedicated to advancing medical knowledge and improving patient care through innovative clinical trials. With a strong emphasis on cardiovascular and respiratory diseases, the foundation integrates cutting-edge research with clinical practice, facilitating the translation of scientific discoveries into tangible health benefits. Committed to ethical standards and patient safety, Fondazione Toscana Gabriele Monasterio collaborates with various academic and healthcare organizations to conduct rigorous studies that contribute to the global understanding of complex health issues.

Locations

Massa, Ms, Italy

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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