Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark

• Register: ClinicalTrials.gov
• Last refreshed on: 18 March 2024
• Main ID: NCT01368666
• Date of registration: 07/06/2011
• Prospective Registration: No
• Primary sponsor: Corcym S.r.l
• Public title: Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark CAVALIER
• Scientific title: Perceval S Valve Clinical Trial for Extended CE Mark
• Date of first enrolment: February 23, 2010
• Target sample size: 658
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT01368666
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria, Belgium, France, Germany, Netherlands, Poland, Switzerland, United Kingdom

Contacts

• Name: A. Haverich, Prof.
• Affiliation: Hannover Medical School

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subjects of age > 65 years;

2. Subjects with aortic valve stenosis or steno-insufficiency;

3. Subjects in which preoperative evaluation indicated the need for native or prosthetic
aortic valve replacement with a biological prosthesis;

4. Subjects willing to sign the informed consent;

5. Subjects willing to undergo all medical follow-up, echocardiography examinations and
laboratory tests planned for the Study

Exclusion Criteria:

1. Subjects involved in any other clinical study for drugs or devices;

2. Subjects with a previously implanted Perceval S prosthesis, within the clinical study,
that requires replacement

3. Subjects with previous implantation of valve prostheses or annuloplasty ring not being
replaced by the study valve

4. Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or
coronary by-pass

5. Subjects who require double or multiple valve replacement or repair in whom the
mitral, tricuspid, or pulmonic valve would be replaced with a non-Perceval S valve or
repaired

6. Subjects with aneurysmal dilation or dissection of the ascending aortic wall

7. Subjects needing non elective intervention

8. Subjects with active endocarditis

9. Subjects with active myocarditis

10. Subjects with congenital bicuspid aortic valve

11. Subjects with aortic root enlargement, where the ratio between the diameter of the
sino-tubular junction and the annulus diameter, assessed by TTE, is > 1.3 (see
Attachment 1 for reference)

12. Subjects with aortic root height (measured from aortic annulus to sino-tubular
junction) = 21 mm for size 21, = 22.5 mm for size 23 and = 24 mm for size 25, and = 25
mm for size XL/27

13. Subjects with myocardial infarction < 90 days before the planned valve implant surgery

14. Subjects with known hypersensitivity to nickel alloys

15. The subject has a documented history of substance (drug or alcohol) abuse

16. The subject is a prison inmate, institutionalized, or is unable to give informed
consent;

17. The subject has a major or progressive non-cardiac disease that, in the investigator's
experience, results in a life expectancy shorter than 1 year, or the implant of the
device produces an unacceptable increased risk to the patient

18. The subject is undergoing renal dialysis for chronic renal failure or has
hyperparathyroidism

19. The subject has had an acute preoperative neurological deficit, myocardial infarction,
or cardiac event that has not returned to baseline or stabilized = 30 days prior to
the planned valve implant surgery



Age minimum: 65 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Aortic Valve Replacement

Intervention(s)

Device: Perceval S Valve Prosthesis

Primary Outcome(s)

Evaluation of haemodynamic performance: Effective Orifice Area (EOA) and Effective Orifice Area indexed (EOAI) [Time Frame: 12 months after OP]

Evaluation of NYHA functional class [Time Frame: 12 months after OP]

Evaluation of haemodynamic performance: mean and peak gradients [Time Frame: 12 months after OP]

Evaluation of haemodynamic performance: Cardiac Index [Time Frame: 12 months after OP]

Evaluation of haemodynamic performance: Cardiac Output [Time Frame: 12 months after OP]

Evaluation of haemodynamic performance: incidence and degree of regurgitation [Time Frame: 12 months after OP]

Evaluation of the safety: Incidence of morbidity [Time Frame: 12 months after OP]

Evaluation of the safety: incidence of mortality [Time Frame: 12 months after OP]

Secondary Outcome(s)

Evaluation of the safety: Incidence of morbidity [Time Frame: up to 10 years]

Evaluation of the safety: Incidence of mortality [Time Frame: up to 10 years]

Evaluation of the safety: Incidence of morbidity [Time Frame: 3-6 months]

Evaluation of haemodynamic performance [Time Frame: 3-6 months]

Evaluation of NYHA functional class [Time Frame: 3-6 months]

Evaluation of the safety: incidence of mortality [Time Frame: 3-6 months]

Evaluation of NYHA functional class [Time Frame: up to 10 years]

Evaluation of haemodynamic performance [Time Frame: up to 10 years]

Secondary ID(s)

TPS001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors