Aortic Valve Stenosis Clinical Trial
Official title:
Clinical Investigation of the Perceval S Sutureless Heart Valve
Verified date | November 2016 |
Source | Sorin Group USA, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 355 |
Est. completion date | April 2018 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
United States | University of Colorado Denver | Aurora | Colorado |
United States | Cardiothoracic and Vascluar Surgeons | Austin | Texas |
United States | University of Maryland | Baltimore | Maryland |
United States | University of Virginia | Charlottesville | Virginia |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Oakwood Hospital | Dearborn | Michigan |
United States | Inova Heart and Vascular Institute | Falls Church | Virginia |
United States | St. Vincent Heart Center of Indiana | Indianapolis | Indiana |
United States | St. Vincent's Medical Center | Jacksonville | Florida |
United States | Baptist Cardiac and Vascular Institute | Miami | Florida |
United States | Lenox Hill/NS-LIJ | New York | New York |
United States | Montefiore Medical Center/Albert Einstein College of Medicine | New York | New York |
United States | New York Presbyterian - Weill Cornell Medical Center | New York | New York |
United States | East Alabama Medical Center | Opelika | Alabama |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Maine Medical Center | Portland | Maine |
United States | Mayo Clinic | Rochester | Minnesota |
United States | University of Washington | Seattle | Washington |
United States | ProMedica Toledo Hospital | Toledo | Ohio |
United States | University of Arizona | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Sorin Group USA, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Supplementary Analyses | Rates of cross-clamp time, cardiopulmonary bypass time, length of stay in ICU, length of hospital, and quality of life | Discharge | No |
Primary | 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 | Yes |
Primary | 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 | No |
Secondary | 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 | No |
Secondary | Secondary Efficacy Outcomes | To demonstrate clinically significant improvements in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications | One-year | No |
Secondary | 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 | No |
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