Status:
COMPLETED
PERCEVAL Pivotal Trial
Lead Sponsor:
Corcym S.r.l
Conditions:
Aortic Valve Replacement
Eligibility:
All Genders
75+ years
Phase:
NA
Brief Summary
The clinical investigation is designed as a prospective and non-randomised study on a maximum of 150 patients. This study will be conducted at Investigational Centres in the European Community. A mini...
Detailed Description
The design of the Perceval S prosthesis stems from the intention to offer an alternative to traditional flexible prostheses (stented and stentless biological valves) using conventional open-heart surg...
Eligibility Criteria
Inclusion
- Subjects of 75 years or older;
- Subjects with aortic valve stenosis or steno-insufficiency;
- Subjects at high surgical risk and candidates for aortic valve replacement with a biological prosthesis;
- Subjects in NYHA functional classes III and IV with the Logistic EuroSCORE greater than 5%.
- Subjects who have agreed to participation in the clinical evaluation and who have signed the informed consent;
- Subjects who are willing to undergo all the medical follow-ups and echocardiographic examinations and laboratory tests that form part of this present protocol.
Exclusion
- Subjects involved in any other clinical study for drugs or devices;
- Subjects who have previously undergone implantation with the Perceval S prosthesis being assessed;
- Subjects with previous implantation of valve prostheses or annuloplasty ring in mitral position;
- Subjects requiring simultaneous procedures, apart from septal myectomy and/or coronary by-pass;
- Subjects with aneurysmal dilation or dissection of the ascending aortic wall needing surgical correction;
- Subjects needing non elective intervention;
- Subjects with aortic annulus (after procedure for decalcification) of dimensions such that the implantation of a valve of size 21 or 23 mm is not possible (direct intra-operative measurement with sizer), in accordance with the indications reported in the Investigator's Brochure;
- Subjects with active endocarditis;
- Subjects with active myocarditis;
- Subjects with any anomaly of the coronary ostia determined through pre-operative coronary angiogram or during intervention itself;
- Subjects with congenital bicuspid aortic valve;
- Subjects with aortic root enlargement, where the ratio between observed and expected diameters (calculated as a function of age and patient body surface area) is \> 1.3;
- Subjects with aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter is \> 1.3;
- Subjects with myocardial infarct \< =90 days;
- Subjects with known hypersensitivity to nickel alloys.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00860730
Start Date
January 1 2009
End Date
October 1 2015
Last Update
July 8 2022
Active Locations (9)
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1
UZ Leuven
Leuven, Belgium, 3000
2
CHRU de Lille
Lille, France, 59037
3
Hopital Guillaume et René Laennec
Nantes, France, 44093
4
Institut Mutualiste Montsouris
Paris, France, 75014