Perceval Aortic Bioprostheses : Durability Study.

NCT07116265 | Completed

• 1 other identifier: IRB-MTP_2023_07_202301441
• Study Type: observational
• Target: 192
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aortic valve replacement is one of the most commonly performed procedures in adult cardiac surgery in France. Patients over the age of 65 most often receive a bioprosthetic aortic valve during an isolated aortic valve replacement or in combination with another cardiac surgery, which may extend the operative time. The Perceval bioprosthesis has the advantage to reduce operative time due to its automatic deployment on a stent, which shortens the suturing time compared to other bioprostheses that require more sutures (sutureless valve). In this retrospective, single-center, observational descriptive study, the investigators are conducting a follow-up of 193 patients operated on at the Montpellier University Hospital between January 2012 and January 2023, who received a Perceval aortic valve as part of routine annual follow-up, in order to assess the durability of this valve based on clinical and echocardiographic Valve Academic Research Consortium 3 (VARC-3) criteria.

Conditions

Stenoses, Aortic Valve; Aortic Insufficiency; Aortic Diseases

Keywords

perceval; durability; degeneration; pacemaker

Outcome Measures

Primary Outcomes (1)

• survival without Bioprosthetic Valve Failure

  From enrollment to the last news (up to 130 months) or death

Secondary Outcomes (6)

• Survival without reoperation

  From enrollment to the last news (up to 130 months) or death

• Survival without structural valve deterioration

  From enrollment to the last news (up to 130 months) or death

• survival without pacemaker implantation

  From enrollment to the last news (up to 130 months) or death

• survival without stroke

  From enrollment to the last news (up to 130 months) or death

• Survival without rehospitalization for cardiac origin

  From enrollment to the last news (up to 130 months) or death

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe or non-severe aortic disease, symptomatic or asymptomatic, who received a rapidly deployed Perceval aortic bioprosthesis between January 1, 2012, and January 31, 2023, in the cardiac surgery department at Montpellier University Hospital.

You may qualify if:

• Patients with severe or non-severe aortic stenosis, symptomatic or asymptomatic, who received a rapidly deployed Perceval aortic bioprosthesis between January 1, 2012, and January 31, 2023, in the cardiac surgery department at Montpellier University Hospital.

You may not qualify if:

• Perceval bioprosthesis explanted during the same surgical procedure.
• History of aortic root surgery.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Related Publications (1)

• 31. Fischlein T, Meuris B, Hakim-Meibodi K, Misfeld M, Carrel T, Zembala M, et al. The sutureless aortic valve at 1 year: A large multicenter cohort study. JTCVS. (2016) ; 151(6):1617-1626.e4. 32. Fischlein T, Meuris B, Folliguet T, Hakim-Meibodi K, Misfeld M, Carrel T, et al. Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study. JTCVS. (2022) ; 164(6):1772-1780.e11. 35. Généreux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, et al. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. JACC. (2021) ; 77(21):2717-46.

  BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency; Aortic Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Vascular Diseases

Study Design

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

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: August 11, 2025
• Study Start: January 1, 2012
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share