Status:
ACTIVE_NOT_RECRUITING
PERCEVAL S Valve Clinical Study for Chinese Registration
Lead Sponsor:
Corcym S.r.l
Conditions:
Aortic Valve Disease
Aortic Valve Stenosis
Eligibility:
All Genders
60+ years
Phase:
NA
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 use...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2024
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03481387
Start Date
January 26 2018
End Date
February 25 2024
Last Update
March 6 2024
Active Locations (1)
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1
Fuwai Hospital CAMS&PUMC
Beijing, China