Aortic Valve Replacement With Trifecta(TM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00475709
First received: May 16, 2007
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

To confirm the clinical safety and effectiveness of the Trifecta valve.


Condition Intervention
Aortic Valve Insufficiency
Regurgitation, Aortic Valve
Aortic Valve Incompetence
Aortic Valve Stenosis
Device: Trifecta Aortic Heart Valve

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Observational, Prospective Evaluation of the Trifecta Valve

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Late Adverse Event Rates [ Time Frame: Events occurring greater than or equal to 31 days post-implant. ] [ Designated as safety issue: Yes ]

    Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events.

    Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]


  • Characterize Patient NYHA Functional Classification Status. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.

    Class I. Patients with cardiac disease but without resulting limitation of physical activity.

    Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.

    Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.

    Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.

    The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.


  • Characterize the Hemodynamic Performance of the Valve. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg.

    Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve.

    Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size.



Enrollment: 1022
Study Start Date: June 2007
Study Completion Date: January 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trifecta Aortic Heart Valve
All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
Device: Trifecta Aortic Heart Valve
Surgical replacement of the aortic valve with the Trifecta Aortic Heart Valve.

Detailed Description:

The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.

  Eligibility

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

Inclusion Criteria:

  • Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time).
  • Legal age.
  • Signed informed consent prior to surgery.
  • Willing to complete all follow-up requirements.

Exclusion Criteria:

  • Pregnant or nursing women.
  • Have already had a valve replaced other than the aortic valve.
  • Needs another valve replaced.
  • Cannot return for required follow-up visits.
  • Have active endocarditis.
  • Acute preoperative neurological event (such as a stroke).
  • Renal dialysis.
  • History of substance abuse within one year, or a prison inmate.
  • Participating in another study.
  • Life expectancy less than two years.
  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: NCT00475709

Locations
United States, California
USC Keck School of Medicine, Dept. of Cardiothoracic Surgery, USC University Hospital
Los Angeles, California, United States, 90033
United States, Florida
Sarasota Memorial Hospital/Clinical Research Center
Sarasota, Florida, United States, 34239
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
NYU Medical Center
New York, New York, United States, 10016
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Mission Hospitals
Asheville, North Carolina, United States, 28801
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Main Line Health Heart Center
Wynnewood, Pennsylvania, United States, 19096
United States, Tennessee
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37212
United States, Texas
Cardiothoracic and Vascular Surgeons
Austin, Texas, United States, 78756
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
United States, Wisconsin
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Hartzell Schaff, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00475709     History of Changes
Other Study ID Numbers: CS0501
Study First Received: May 16, 2007
Results First Received: September 19, 2012
Last Updated: January 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Medical:
aortic valve
heart valve
tissue valve
bioprosthesis
valve disorder
valve disease
cardiac surgery
aortic valve stenosis
aortic valve regurgitation

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 24, 2014