Perceval S Aortic Heart Valve Study- North America

• Register: ClinicalTrials.gov
• Last refreshed on: 28 November 2016
• Main ID: NCT01810679
• Date of registration: 07/03/2013
• Prospective Registration: Yes
• Primary sponsor: Sorin Group USA, Inc.
• Public title: Perceval S Aortic Heart Valve Study- North America
• Scientific title: Clinical Investigation of the Perceval S Sutureless Heart Valve
• Date of first enrolment: April 2013
• Target sample size: 355
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01810679
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Rakesh Suri, MD, DPhil
• Affiliation: The Cleveland Clinic

Key inclusion & exclusion criteria

Inclusion criteria:

1. Subjects of age >= 18 years.

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

3. The subject is willing to sign the informed consent.

4. The subject in which preoperative evaluation indicated the need for native or
prosthetic aortic valve replacement.

5. The subject is located in a geographic location that will enable the subject to
return to the study site for all follow-up examinations (i.e. geographically stable).

6. Subject will be available to the investigator(s) for postoperative follow-up beyond
one year.

Exclusion criteria:

1. The subject has preexisting valve prosthesis or annuloplasty ring in the mitral,
pulmonic or tricuspid position.

2. The subject requires a double or multiple valve replacement or repair of the mitral,
tricuspid, or pulmonic valve.

3. The subject has a previously implanted PERCEVAL valve that requires replacement.

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

5. The subject has active endocarditis.

6. Subjects with active myocarditis

7. The subject is or will be participating in a concomitant research study of an
investigational product.

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

9. The subject is a minor, drug abuser, alcohol abuser, prison inmate,
institutionalized, or is unable to give informed consent.

10. The 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 patient.

11. Subjects with known hypersensitivity to nickel alloys.

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

13. 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.

14. Subject is known to be noncompliant or is unlikely to complete the study.

15. Subjects with an aortic root enlargement, where the ratio between the diameter of the
sino-tubular junction and the annulus diameter, assessed by TTE, is > 1.3.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Aortic Valve Stenosis

Aortic Valve Stenosis With Insufficiency

Regurgitation, Aortic Valve

Aortic Valve Incompetence

Intervention(s)

Device: Perceval S Aortic Heart Valve

Primary Outcome(s)

Primary Efficacy Endpoint [Time Frame: One-year]

Primary Safety Endpoint [Time Frame: One-year]

Secondary Outcome(s)

Secondary Efficacy Outcomes [Time Frame: One-year]

Secondary ID(s)

G120053

Source(s) of Monetary Support

Please refer to primary and secondary sponsors