CT Scan Sizing for Perceval Sutureless Valve

NCT ID: NCT05799573

Last Updated: 2024-12-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2025-01-30

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.

Conditions

Aortic Valve Regurgitation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maria Cecilia Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisa Mikus, MD

Role: PRINCIPAL_INVESTIGATOR

Maria Cecilia Hospital

Locations

Maria Cecilia Hospital

Cotignola, Ravenna, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Elisa Mikus, MD

Role: CONTACT

emikus@gvmnet.it

0545/217678 ext. +39

Facility Contacts

Elisa Mikus, MD

Role: primary

emikus@gvmnet.it

0545/217678 ext. +39

Other Identifiers

PERCEVAL

Identifier Type: -

Identifier Source: org_study_id