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OpenTrials
Completed

NCT Number: NCT05799573

CT Scan Sizing for Perceval Sutureless Valve

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maria Cecilia Hospital

Cotignola, Ravenna, 48033, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female subjects > 18 years;
  • Subjects willing to sign and date an informed consent for treatment of personal data;
  • Subjects willing and able to comply with the follow up schedule of the protocol;
  • Subjects with indication for aortic valve replacement on a tricuspid aortic valve;
  • Subjects with possibly associated need for coronary revascularization.
  • Subjects with Ejection Fraction ≥ 40%

Exclusion criteria

  • Male and female subjects ≤ 18 years;
  • Subjects with bicuspid aortic valve
  • Subjects with associated mitral valvulopathy or ascending aorta aneurysm
  • Subjects with pure aortic insufficiency
  • Subjects with Ejection Fraction < 40%
  • Subjects with acute myocardial infarction < 30 gg
  • Subjects with serum creatinine > 2 mg/Dl

Treatment and study plan

Primary outcomes

  1. Evaluate the proper Perceval valve size assessed by the early postoperative outcomes at discharge

    Time frame: 12 months

    The primary endpoint is to evaluate the proper Perceval valve size assessed by the early postoperative outcomes at discharge in terms of:

    • Mean and peak pressure gradients
    • Prosthetic regurgitation
    • migration/dislodgement
    • need for permanent pacemaker implant

Sponsors and collaborators

Lead sponsor

Maria Cecilia Hospital

Other

Registry information

Official study title

CT-scan Sizing Perceval Sutureless Valve

Acronym: PERCEVAL

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 5, 2023
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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