Brief Title
Perceval S Aortic Heart Valve Study- North America
Official Title
Clinical Investigation of the Perceval S Sutureless Heart Valve
Brief Summary
To demonstrate the safety and effectiveness of the Perceval S heart valve when used to
replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
Detailed Description
This investigation is a prospective, non-randomized, multi-center trial of the PERCEVAL valve
implanted in patients requiring aortic valve replacement. The study will be conducted in a
maximum of 25 centers in the United States. Patients will be evaluated at each of the
following time intervals:preoperative, at implant, in the early postoperative period, in the
late postoperative period (between 3 and 6 months postoperatively), at 1 year (between 11 and
13 months postoperatively), and annually until study completion. The duration of the study is
anticipated to be 5 years.
Study Type
Interventional
Primary Outcome
Primary Safety Endpoint
Secondary Outcome
Secondary Efficacy Outcomes
Condition
Aortic Valve Stenosis
Intervention
Perceval S Aortic Heart Valve
Study Arms / Comparison Groups
Perceval S Aortic Heart Valve
Description: Treatment with the Perceval S Aortic Heart Valve
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
355
Start Date
April 2013
Completion Date
April 2018
Primary Completion Date
February 2016
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Rakesh Suri, MD, DPhil, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01810679
Organization ID
G120053
Responsible Party
Sponsor
Study Sponsor
Sorin Group USA, Inc.
Study Sponsor
Rakesh Suri, MD, DPhil, Principal Investigator, The Cleveland Clinic
Verification Date
November 2016