NCT05799573

CT Scan Sizing for Perceval Sutureless Valve

CT-scan Sizing Perceval Sutureless Valve

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Maria Cecilia Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Recent evidence in TAVI patients suggests that significant underexpansion or distortion of valved stents may be associated with altered leaflet function, leading to increased transprosthetic gradients and possibly predisposing to other negative outcomes such as valve thrombosis, low platelet counts, thromboembolic events, and early degeneration . Moreover, there is evidence that excessive oversizing of the Perceval valve is detrimental. The present study is aimed to investigate the relationship between the CT-derived measure of the annulus dimension and early hemodynamic and clinical outcomes in patients undergoing sutureless aortic valve replacement (AVR) with the Perceval sutureless aortic valve and define the Perceval sizing chart based on preoperative CT-scan measurements.

Conditions

• Aortic Valve Regurgitation

Timeline

• Start date: 2022-12-01
• Primary completion: 2025-01-01
• Completion: 2025-01-30
• First posted: 2023-04-05
• Last updated: 2024-12-02

Locations

1 site across 1 country: Italy