CT Scan Sizing for Perceval Sutureless Valve (PERCEVAL)

CT-scan Sizing 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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Regurgitation

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Elisa Mikus, MD; Phone Number: +39 0545/217678; Email: emikus@gvmnet.it

Study Locations

• Italy
  • Ravenna
    • Cotignola, Ravenna, Italy, 48033
      • Recruiting
      • Maria Cecilia Hospital
      • Contact: Elisa Mikus, MD; Phone Number: +39 0545/217678; Email: emikus@gvmnet.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with indication for aortic valve replacement with a Perceval valve

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Maria Cecilia Hospital
• Investigators: Principal Investigator: Elisa Mikus, MD, Maria Cecilia Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: PERCEVAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

All information related to the participation of a subject in this study will be treated with the utmost confidentiality, in accordance with good clinical practice (Decree of the Ministry of Health of 15 July 1997, and subsequent amendments and additions) and regulations on the protection of personal data: Information and Consent pursuant to Legislative Decree no. 196 of 30/06/2003 and the European General Data Protection Regulation (GDPR - General Data Protection Regulation), which came into force on 25 May 2018.

All patient names will be kept confidential. Patients will be identified throughout documentation and evaluation by the number allotted to them by the study. The patients will be assured that all findings will be stored on computer and handled in the strictest confidence. The Investigator agrees to maintain the confidentiality of the study protocol.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No