Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population

NCT06011148 | Not Yet Recruiting FDA Device

• 1 other identifier: CCH803
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the study is to evaluate the safety information on the Perceval S sutureless prosthetic heart valve after the implantation for aortic valve disease. The study is designed as a post-market, observational, non-interventional retrospective and prospective registry.

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (8)

• Mortality

  The number and percentage of subjects died

  up to 1 year

• Structural valve deterioration

  The number and percentage of subjects with Structural valve deterioration

  up to 1 year

• Cerebral thromboembolism

  The number and percentage of subjects with Cerebral thromboembolism

  up to 1 year

• Stroke

  The number and percentage of subjects with stroke

  up to 1 year

• Transient Ischemic Attack (TIA)

  The number and percentage of subjects with Transient Ischemic Attack (TIA)

  up to 1 year

• Non-cerebral thromboembolism

  The number and percentage of subjects with non-cerebral thromboembolism

  up to 1 year

• Major bleeding

  The number and percentage of subjects with major bleeding

  up to 1 year

• Re-operation

  The number and percentage of subjects with re-operation

  up to 1 year

Secondary Outcomes (5)

• Aortic Mean Pressure Gradient (MPG)

  at discharge or 7 days post-procedure (whichever comes first)

• Aortic Peak Pressure Gradient (PPG)

  at discharge or 7 days post-procedure (whichever comes first)

• Effective Orifice Area (EOA)

  at discharge or 7 days post-procedure (whichever comes first)

• Effective Orifice Area Index (EOAi)

  at discharge or 7 days post-procedure (whichever comes first)

• Aortic Regurgitation

  at discharge or 7 days post-procedure (whichever comes first),

Study Arms (1)

Subject implanted with Perceval S sutureless prosthetic heart valve

Subjects who have been implanted with Perceval S sutureless prosthetic heart valve from 2022 onward and subjects that will be implanted up to study closure.

Device: Perceval S sutureless heart valve

Interventions

Perceval S sutureless heart valve DEVICE

Aortic Valve Replacement with Perceval S sutureless heart valve

Subject implanted with Perceval S sutureless prosthetic heart valve

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have been implanted with Perceval S sutureless prosthetic heart valve from 2022 onward and subjects that will be implanted up to study closure.

You may qualify if:

• Subject who has been implanted with Perceval S sutureless aortic heart valve
• Subject (legal representative or family member) who has signed the approved informed consent or would provide verbal informed consent/ signed and dated informed consent, and available medical information

You may not qualify if:

• \. Subject (legal representative or family member) who do not provide consent to the data collection

Sponsors & Collaborators

• Corcym S.r.l: lead

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Sara Gaggianesi

  Corcym S.r.l

  STUDY DIRECTOR

Central Study Contacts

Steven Zhang

CONTACT

+86 138 1023 2090; steven.zhang@corcym.com

Michela Paroli

CONTACT

+393488660149; michela.paroli@corcym.com

Study Design

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

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 25, 2023
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03