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

• Sponsor: Corcym S.r.l (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06011148
• Collaborator: (none)
• Enrollment: 80
• Anticipated Duration (Months): 15

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Disease	Device: Perceval S sutureless heart valve

Detailed Description

In order to monitor the ongoing safety of the Perceval S as part of regulatory requirements, the study aims to retrospectively collect safety outcomes and performance data in patients with aortic valve disease implanted with Perceval S since 2022. The data will be used for regulatory purposes, to support the re-certification of the valve in the Chinese market.

Serious Adverse Events (SAEs) such as valve-related death, structural valve deterioration, cerebral thromboembolism, stroke, Transient Ischemic Attack, non-cerebral thromboembolism, major bleeding, re-operation will be studied to describe the safety profile of the valve.

Hemodynamic data from site reported echocardiography finding (mean gradient, peak gradient, effective orifice area, effective orifice area indexed, incidence and degree of PVL and central leak) at hospital discharge will also be evaluated. Data of approximately 80 subjects will be collected in four clinical sites in China.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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; Aortic Valve Replacement with Perceval S sutureless heart valve

Outcome Measures

Primary Outcome Measures

1. Mortality [up to 1 year]

   The number and percentage of subjects died

2. Structural valve deterioration [up to 1 year]

   The number and percentage of subjects with Structural valve deterioration

3. Cerebral thromboembolism [up to 1 year]

   The number and percentage of subjects with Cerebral thromboembolism

4. Stroke [up to 1 year]

   The number and percentage of subjects with stroke

5. Transient Ischemic Attack (TIA) [up to 1 year]

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

6. Non-cerebral thromboembolism [up to 1 year]

   The number and percentage of subjects with non-cerebral thromboembolism

7. Major bleeding [up to 1 year]

   The number and percentage of subjects with major bleeding

8. Re-operation [up to 1 year]

   The number and percentage of subjects with re-operation

Secondary Outcome Measures

1. Aortic Mean Pressure Gradient (MPG) [at discharge or 7 days post-procedure (whichever comes first)]

   Decrease of MPG from baseline

2. Aortic Peak Pressure Gradient (PPG) [at discharge or 7 days post-procedure (whichever comes first)]

   Decrease of PPG from baseline

3. Effective Orifice Area (EOA) [at discharge or 7 days post-procedure (whichever comes first)]

   Increase of EOA from baseline

4. Effective Orifice Area Index (EOAi) [at discharge or 7 days post-procedure (whichever comes first)]

   Increase of EOAi from baseline

5. Aortic Regurgitation [at discharge or 7 days post-procedure (whichever comes first),]

   incidence and degree of paravalvular and central leak

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject who has been implanted with Perceval S sutureless aortic heart valve

2. 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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Corcym S.r.l

Investigators

• Study Director: Mara Chiaro, Corcym S.r.l

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Corcym S.r.l
• ClinicalTrials.gov Identifier: NCT06011148
• Other Study ID Numbers: CCH803
• First Posted: Aug 25, 2023
• Last Update Posted: Aug 25, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Aortic Valve Disease

Study Results

No Results Posted as of Aug 25, 2023