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CT Scan Sizing for Perceval Sutureless Valve

NCT05799573 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-05-13

No results posted yet for this study

Summary

The Perceval sutureless aortic bioprosthesis is a bovine pericardium valve mounted in a nitinol stent that can be compressed and positioned in a valve delivery system. Similarly, to transcatheter aortic valve implantation (TAVI) devices, the anchoring and good sealing of the Perceval bioprosthesis relies on oversizing by design of the nitinol stent compared with the native aortic annulus. With the advent of TAVI, cardiac computed tomography (CT) has become the gold standard technique for measuring the aortic annulus in patients undergoing transcatheter procedures, and the CT-derived axial image of the aortic virtual basal ring (VBR) is considered as the reference for sizing by most of the manufacturers of transcatheter valves .

Interestingly, the VBR lies exactly on the plane passing through the nadir of the 3 aortic cusps, that is where, according to the instructions for use, a correctly positioned Perceval valve should be deployed. VBR could then provide a good estimate of the annular dimension for the Perceval pre-operative sizing.

Conditions

  • Aortic Valve Regurgitation

Sponsors & Collaborators

  • Maria Cecilia Hospital

    lead OTHER

Principal Investigators

  • Elisa Mikus, MD · Maria Cecilia Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2026-04-01
Completion
2026-04-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05799573 on ClinicalTrials.gov