Perceval S Aortic Heart Valve Study- North America

Study Overview
=================
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.

Official Title
-----------------
Clinical Investigation of the Perceval S Sutureless Heart Valve

Conditions
-----------------
Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence

Intervention / Treatment
-----------------
* Device: Perceval S Aortic Heart Valve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subjects of age >= 18 years. Subjects with aortic valve stenosis or steno-insufficiency. The subject is willing to sign the informed consent. The subject in which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement. 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). Subject will be available to the investigator(s) for postoperative follow-up beyond one year. Exclusion criteria: The subject has preexisting valve prosthesis or annuloplasty ring in the mitral, pulmonic or tricuspid position. The subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve. The subject has a previously implanted PERCEVAL valve that requires replacement. Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass. The subject has active endocarditis. Subjects with active myocarditis The subject is or will be participating in a concomitant research study of an investigational product. Subjects with aneurysmal dilation or dissection of the ascending aortic wall. The subject is a minor, drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent. 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. Subjects with known hypersensitivity to nickel alloys. The subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism. 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. Subject is known to be noncompliant or is unlikely to complete the study. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perceval S Aortic Heart Valve<br>Treatment with the Perceval S Aortic Heart Valve | Device: Perceval S Aortic Heart Valve<br>* Perceval S Sutureless Aortic Heart Valve<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint | To demonstrate that the complication and survival rates for the PERCEVAL S valve are comparable to appropriate historical controls manifested as objective performance criteria (OPCs) and to that reported for other stented bioprostheses in the literature | One-year | 
| Primary Efficacy Endpoint | To demonstrate that the rate of valve success for the PERCEVAL S valve is comparable to that of appropriate historical controls | One-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Efficacy Outcomes | To demonstrate that the hemodynamic performance of the PERCEVAL S valve is comparable to that reported in the literature for other stented aortic bioprostheses | One-year | 
| Secondary Efficacy Outcomes | To demonstrate clinically significant improvements in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications | One-year | 
| Secondary Efficacy Outcomes | To demonstrate that the rate of device technical success for the PERCEVAL S valve is comparable to that of appropriate historical controls | One-year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aortic valve replacement, aortic stenosis, aortic steno-insufficiency, Perceval, Sutureless aortic heart valve