Perceval S Aortic Heart Valve Study- North America

Aortic Valve Stenosis Clinical Trial

Official title:

Clinical Investigation of the Perceval S Sutureless Heart Valve

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01810679
• Other study ID #: G120053
• Status: Terminated
• Phase: N/A
• First received: March 7, 2013
• Last updated: November 15, 2016
• Start date: April 2013
• Est. completion date: April 2018

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Incompetence
• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Aortic Valve Stenosis With Insufficiency
• Constriction, Pathologic
• Heart Defects, Congenital
• Heart Valve Diseases
• Regurgitation, Aortic Valve

Intervention

Device:
• Perceval S Aortic Heart Valve
Perceval S Sutureless Aortic Heart Valve

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sorin Group USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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