Clinical trial NCT06011148: Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population
Official title: Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aortic Valve Disease
Lead sponsor: Corcym S.r.l
Sponsor class: INDUSTRY
First posted: 2023-08-25
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: up to 1 year
measure: Structural valve deterioration
timeFrame: up to 1 year
measure: Cerebral thromboembolism
timeFrame: up to 1 year
measure: Stroke
timeFrame: up to 1 year
measure: Transient Ischemic Attack (TIA)
timeFrame: up to 1 year
measure: Non-cerebral thromboembolism
timeFrame: up to 1 year
measure: Major bleeding
timeFrame: up to 1 year
measure: Re-operation
timeFrame: up to 1 year
Secondary outcomes:
measure: Aortic Mean Pressure Gradient (MPG)
timeFrame: at discharge or 7 days post-procedure (whichever comes first)
measure: Aortic Peak Pressure Gradient (PPG)
timeFrame: at discharge or 7 days post-procedure (whichever comes first)
measure: Effective Orifice Area (EOA)
timeFrame: at discharge or 7 days post-procedure (whichever comes first)
measure: Effective Orifice Area Index (EOAi)
timeFrame: at discharge or 7 days post-procedure (whichever comes first)
measure: Aortic Regurgitation
timeFrame: at discharge or 7 days post-procedure (whichever comes first),
Other outcomes:
Locations:
Study officials:
affiliation: Corcym S.r.l
name: Sara Gaggianesi
role: STUDY_DIRECTOR
References: