Perceval S Aortic Heart Valve Study- North America

Clinical Investigation of the Perceval S Sutureless Heart Valve

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.

Study Overview

• Status: Terminated
• Conditions: Aortic Valve Stenosis; Aortic Valve Stenosis With Insufficiency; Regurgitation, Aortic Valve; Aortic Valve Incompetence
• Intervention / Treatment: Device: Perceval S Aortic Heart Valve

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
• Enrollment (Actual): 355
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Opelika, Alabama, United States, 36801
      • East Alabama Medical Center
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Florida
    • Jacksonville, Florida, United States, 32204
      • St. Vincent's Medical Center
    • Miami, Florida, United States, 33176
      • Baptist Cardiac and Vascular Institute
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Heart Center of Indiana
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Oakwood Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10065
      • New York Presbyterian - Weill Cornell Medical Center
    • New York, New York, United States, 10467
      • Montefiore Medical Center/Albert Einstein College of Medicine
    • New York, New York, United States, 11075
      • Lenox Hill/NS-LIJ
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • Austin, Texas, United States, 78756
      • Cardiothoracic and Vascluar Surgeons
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Heart and Vascular Institute
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supplementary Analyses	Rates of cross-clamp time, cardiopulmonary bypass time, length of stay in ICU, length of hospital, and quality of life	Discharge

Collaborators and Investigators

• Sponsor: Sorin Group USA, Inc.
• Investigators: Principal Investigator: Rakesh Suri, MD, DPhil, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: March 7, 2013
• First Submitted That Met QC Criteria: March 11, 2013
• First Posted (Estimate): March 13, 2013

Study Record Updates

• Last Update Posted (Estimate): November 16, 2016
• Last Update Submitted That Met QC Criteria: November 15, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: aortic valve replacement; aortic stenosis; aortic steno-insufficiency; Perceval; Sutureless aortic heart valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency; Constriction, Pathologic
• Other Study ID Numbers: G120053

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No