Perceval S Aortic Heart Valve Study- North America

• Sponsor: Sorin Group USA, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01810679
• Collaborator: (none)
• Enrollment: 355
• Locations: 21
• Arm: 1
• Duration (Months): 60
• Patients Per Site: 16.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis; Aortic Valve Stenosis With Insufficiency; Regurgitation, Aortic Valve; Aortic Valve Incompetence	Device: Perceval S Aortic Heart Valve	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 355 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Investigation of the Perceval S Sutureless Heart Valve
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Feb 1, 2016
• Anticipated Study Completion Date: Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Perceval S Aortic Heart Valve Treatment with the Perceval S Aortic Heart Valve	Device: Perceval S Aortic Heart Valve; Perceval S Sutureless Aortic Heart Valve

Outcome Measures

Primary Outcome Measures

1. Primary Safety Endpoint [One-year]

   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

2. Primary Efficacy Endpoint [One-year]

   To demonstrate that the rate of valve success for the PERCEVAL S valve is comparable to that of appropriate historical controls

Secondary Outcome Measures

1. Secondary Efficacy Outcomes [One-year]

   To demonstrate that the hemodynamic performance of the PERCEVAL S valve is comparable to that reported in the literature for other stented aortic bioprostheses

2. Secondary Efficacy Outcomes [One-year]

   To demonstrate clinically significant improvements in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications

3. Secondary Efficacy Outcomes [One-year]

   To demonstrate that the rate of device technical success for the PERCEVAL S valve is comparable to that of appropriate historical controls

Other Outcome Measures

1. Supplementary Analyses [Discharge]

   Rates of cross-clamp time, cardiopulmonary bypass time, length of stay in ICU, length of hospital, and quality of life

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Alabama Medical Center	Opelika	Alabama	United States	36801
2	University of Arizona	Tucson	Arizona	United States	85724
3	University of Colorado Denver	Aurora	Colorado	United States	80045
4	St. Vincent's Medical Center	Jacksonville	Florida	United States	32204
5	Baptist Cardiac and Vascular Institute	Miami	Florida	United States	33176
6	Emory University	Atlanta	Georgia	United States	30308
7	St. Vincent Heart Center of Indiana	Indianapolis	Indiana	United States	46290
8	Maine Medical Center	Portland	Maine	United States	04102
9	University of Maryland	Baltimore	Maryland	United States	21201
10	Oakwood Hospital	Dearborn	Michigan	United States	48124
11	Mayo Clinic	Rochester	Minnesota	United States	55905
12	New York Presbyterian - Weill Cornell Medical Center	New York	New York	United States	10065
13	Montefiore Medical Center/Albert Einstein College of Medicine	New York	New York	United States	10467
14	Lenox Hill/NS-LIJ	New York	New York	United States	11075
15	Cleveland Clinic	Cleveland	Ohio	United States	44195
16	ProMedica Toledo Hospital	Toledo	Ohio	United States	43606
17	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
18	Cardiothoracic and Vascluar Surgeons	Austin	Texas	United States	78756
19	University of Virginia	Charlottesville	Virginia	United States	22908
20	Inova Heart and Vascular Institute	Falls Church	Virginia	United States	22042
21	University of Washington	Seattle	Washington	United States	98195

Sponsors and Collaborators

• Sorin Group USA, Inc.

Investigators

• Principal Investigator: Rakesh Suri, MD, DPhil, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sorin Group USA, Inc.
• ClinicalTrials.gov Identifier: NCT01810679
• Other Study ID Numbers: G120053
• First Posted: Mar 13, 2013
• Last Update Posted: Nov 16, 2016
• Last Verified: Nov 1, 2016

• Keywords provided by Sorin Group USA, Inc.: aortic valve replacement; aortic stenosis; aortic steno-insufficiency; Perceval; Sutureless aortic heart valve
• Additional relevant MeSH terms: Aortic Valve Stenosis; Aortic Valve Insufficiency; Constriction, Pathologic

Study Results

No Results Posted as of Nov 16, 2016