Back to resultsPERCEVAL S Valve Clinical Study for Chinese Registration (PERFECT)
Primary Purpose
Aortic Valve Disease, Aortic Valve Stenosis
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Aortic Valve Replacement with Perceval S sutureless heart valve
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Disease
Eligibility Criteria
Inclusion Criteria:
- Subject of age > 60 years.
- Subject with aortic valve stenosis or steno-insufficiency.
- Subject has signed the informed consent.
- Subject in which preoperative evaluation is indicated for the need of native or prosthetic aortic valve replacement via open heart surgery
- Subject is located in a geographic location that will enable the subject to return to the study site for follow-up examinations (i.e. geographically stable).
Exclusion Criteria:
- Subject has preexisting valve prosthesis or annuloplasty rings in the mitral, pulmonic or tricuspid position.
- Subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve.
- Subject requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass graft (CABG).
- Subject has active endocarditis.
- Subject has active myocarditis
- Subject has aneurysmal dilation or dissection of the ascending aortic wall.
- Subject is drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.
- Subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the subject.
- Subject with known hypersensitivity to nickel alloys.
- Subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism.
- Subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized for ≥30 days prior to the planned valve implant surgery.
- Subject is known to be noncompliant or is unlikely to complete the study.
- Subject with an aortic root enlargement, where the ratio between the diameter of the STJ and the annulus diameter, assessed by TEE, is > 1.3. Or for other anatomical reasons that not suitable for PERCEVAL S per IB.
Sites / Locations
- Fuwai Hospital CAMS&PUMC
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Aortic Valve Replacement with Perceval S sutureless heart valve
Arm Description
Patient undergoing Aortic Valve Replacement with Perceval S sutureless heart valve
Outcomes
Primary Outcome Measures
composite endpoint of thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death (>30 days)
The primary endpoint includes thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death (>30 days) per CEC adjudication
The number and percentage of subjects with free from thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death will be presented, along with individual component of the success.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03481387
Brief Title
PERCEVAL S Valve Clinical Study for Chinese Registration
Acronym
PERFECT
Official Title
PERCEVAL S Valve Clinical Study for Chinese Registration
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 26, 2018 (Actual)
Primary Completion Date
September 25, 2020 (Actual)
Study Completion Date
February 25, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corcym S.r.l
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, open, single arm, multi-center clinical study in China. The primary objective of this study is to demonstrate the safety and effectiveness of the PERCEVAL S heart valve when used to replace a diseased native or malfunctioning prosthetic aortic valve in the indicated Chinese population for tissue heart valve replacement and suitable to the PERCEVAL S valve.
The secondary objectives are to collect all relevant device and subject demographics, procedural and hospital discharge, short and long-term data, as described in the secondary endpoints section.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease, Aortic Valve Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aortic Valve Replacement with Perceval S sutureless heart valve
Arm Type
Other
Arm Description
Patient undergoing Aortic Valve Replacement with Perceval S sutureless heart valve
Intervention Type
Device
Intervention Name(s)
Aortic Valve Replacement with Perceval S sutureless heart valve
Intervention Description
Patients will be treated with the PERCEVAL S heart valve (PERCEVAL S valve) which is a bioprosthesis manufactured with bovine pericardium and assembled on a Nitinol stent. The PERCEVAL S valve is designed to offer an alternative to surgically implanted flexible prostheses (stented and stentless biological valves). A special feature of the device is that it is self-anchoring and does not require sutures to be fixed to the implant site.
Primary Outcome Measure Information:
Title
composite endpoint of thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death (>30 days)
Description
The primary endpoint includes thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death (>30 days) per CEC adjudication
The number and percentage of subjects with free from thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death will be presented, along with individual component of the success.
Time Frame
at one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject of age > 60 years.
Subject with aortic valve stenosis or steno-insufficiency.
Subject has signed the informed consent.
Subject in which preoperative evaluation is indicated for the need of native or prosthetic aortic valve replacement via open heart surgery
Subject is located in a geographic location that will enable the subject to return to the study site for follow-up examinations (i.e. geographically stable).
Exclusion Criteria:
Subject has preexisting valve prosthesis or annuloplasty rings in the mitral, pulmonic or tricuspid position.
Subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve.
Subject requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass graft (CABG).
Subject has active endocarditis.
Subject has active myocarditis
Subject has aneurysmal dilation or dissection of the ascending aortic wall.
Subject is drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.
Subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the subject.
Subject with known hypersensitivity to nickel alloys.
Subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism.
Subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized for ≥30 days prior to the planned valve implant surgery.
Subject is known to be noncompliant or is unlikely to complete the study.
Subject with an aortic root enlargement, where the ratio between the diameter of the STJ and the annulus diameter, assessed by TEE, is > 1.3. Or for other anatomical reasons that not suitable for PERCEVAL S per IB.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Gaggianesi
Organizational Affiliation
LivaNova
Official's Role
Study Director
Facility Information:
Facility Name
Fuwai Hospital CAMS&PUMC
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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PERCEVAL S Valve Clinical Study for Chinese Registration
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