CT Scan Sizing for Perceval Sutureless Valve

Aortic Valve Regurgitation Clinical Trial

— PERCEVAL  

Official title:

CT-scan Sizing Perceval Sutureless Valve

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05799573
• Other study ID #: PERCEVAL
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: Maria Cecilia Hospital
• Contact: Elisa Mikus, MD
• Phone: 0545/217678
• Email: emikus[@]gvmnet.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Regurgitation

Locations

Country	Name	City	State
Italy	Maria Cecilia Hospital	Cotignola	Ravenna

Sponsors (1)

Lead Sponsor	Collaborator
Maria Cecilia Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the proper Perceval valve size assessed by the early postoperative outcomes at discharge	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	12 months