Clinical trial NCT05799573: CT Scan Sizing for Perceval Sutureless Valve
Official title: CT-scan Sizing Perceval Sutureless Valve
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Regurgitation
Lead sponsor: Maria Cecilia Hospital
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with indication for aortic valve replacement with a Perceval valve

Brief 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Evaluate the proper Perceval valve size assessed by the early postoperative outcomes at discharge
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
state: Ravenna
Study officials:
affiliation: Maria Cecilia Hospital
name: Elisa Mikus, MD
role: PRINCIPAL_INVESTIGATOR
References: