Aortic Valve Replacement With Trifecta(TM)

An Observational, Prospective Evaluation of the Trifecta Valve

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

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency; Regurgitation, Aortic Valve; Aortic Valve Incompetence
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 1022
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late Adverse Event Rates	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]	Events occurring greater than or equal to 31 days post-implant.
Characterize Patient NYHA Functional Classification Status.	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.	1 year
Characterize the Hemodynamic Performance of the Valve.	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.	1 year

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Hartzell Schaff, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: May 16, 2007
• First Submitted That Met QC Criteria: May 17, 2007
• First Posted (Estimate): May 21, 2007

Study Record Updates

• Last Update Posted (Actual): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: cardiac surgery; bioprosthesis; aortic valve stenosis; aortic valve; heart valve; tissue valve; valve disorder; valve disease; aortic valve regurgitation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency
• Other Study ID Numbers: CS0501