CT Scan Sizing for Perceval Sutureless Valve

NCT05799573 | Recruiting

• 1 other identifier: PERCEVAL
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Regurgitation

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with indication for aortic valve replacement with a Perceval valve

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria Cecilia Hospital: lead

Study Sites (1)

Maria Cecilia Hospital

Cotignola, Ravenna, 48033, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Elisa Mikus, MD

  Maria Cecilia Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Mikus, MD

CONTACT

0545/217678; emikus@gvmnet.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: December 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 30, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)