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Perceval S Aortic Heart Valve Study- North America

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sorin Group USA, Inc.
ClinicalTrials.gov Identifier:
NCT01810679
First received: March 7, 2013
Last updated: January 9, 2015
Last verified: January 2015
  Purpose

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 Intervention
Aortic Valve Stenosis
Aortic Valve Stenosis With Insufficiency
Regurgitation, Aortic Valve
Aortic Valve Incompetence
Device: Perceval S Aortic Heart Valve

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Investigation of the Perceval S Sutureless Heart Valve

Resource links provided by NLM:


Further study details as provided by Sorin Group USA, Inc.:

Primary Outcome Measures:
  • Primary Safety Endpoint [ Time Frame: One-year ] [ Designated as safety issue: Yes ]
    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

  • Primary Efficacy Endpoint [ Time Frame: One-year ] [ Designated as safety issue: No ]
    To demonstrate that the rate of valve success for the PERCEVAL S valve is comparable to that of appropriate historical controls


Secondary Outcome Measures:
  • Secondary Efficacy Outcomes [ Time Frame: One-year ] [ Designated as safety issue: No ]
    To demonstrate that the hemodynamic performance of the PERCEVAL S valve is comparable to that reported in the literature for other stented aortic bioprostheses

  • Secondary Efficacy Outcomes [ Time Frame: One-year ] [ Designated as safety issue: No ]
    To demonstrate clinically significant improvements in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications

  • Secondary Efficacy Outcomes [ Time Frame: One-year ] [ Designated as safety issue: No ]
    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:
  • Supplementary Analyses [ Time Frame: Discharge ] [ Designated as safety issue: No ]
    Rates of cross-clamp time, cardiopulmonary bypass time, length of stay in ICU, length of hospital, and quality of life


Estimated Enrollment: 300
Study Start Date: April 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01810679

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
St. Vincent's Medical Center
Jacksonville, Florida, United States, 32204
Baptist Cardiac and Vascular Institute
Miami, Florida, United States, 33176
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30308
United States, Indiana
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States, 46290
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
Oakwood Hospital
Dearborn, Michigan, United States, 48124
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Montefiore Medical Center/Albert Einstein College of Medicine
New York, New York, United States, 10467
Lenox Hill/NS-LIJ
New York, New York, United States, 11075
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
ProMedica Toledo Hospital
Toledo, Ohio, United States, 43606
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Cardiothoracic and Vascluar Surgeons
Austin, Texas, United States, 78756
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Inova Heart and Vascular Institute
Falls Church, Virginia, United States, 22042
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Sorin Group USA, Inc.
Investigators
Principal Investigator: Rakesh Suri, MD, DPhil Mayo Clinic- Rochester, MN
  More Information

No publications provided

Responsible Party: Sorin Group USA, Inc.
ClinicalTrials.gov Identifier: NCT01810679     History of Changes
Other Study ID Numbers: G120053
Study First Received: March 7, 2013
Last Updated: January 9, 2015
Health Authority: United States: Food and Drug Administration

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 Insufficiency
Aortic Valve Stenosis
Heart Defects, Congenital
Heart Valve Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on February 27, 2015