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Aortic Valve Replacement With Trifecta(TM)

Primary Purpose

Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trifecta Aortic Heart Valve
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Insufficiency focused on measuring aortic valve, heart valve, tissue valve, bioprosthesis, valve disorder, valve disease, cardiac surgery, aortic valve stenosis, aortic valve regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • USC Keck School of Medicine, Dept. of Cardiothoracic Surgery, USC University Hospital
  • Sarasota Memorial Hospital/Clinical Research Center
  • Loyola University Medical Center
  • William Beaumont Hospital
  • Abbott Northwestern Hospital
  • Mayo Clinic
  • NYU Medical Center
  • Columbia University Medical Center
  • Mission Hospitals
  • Duke University Medical Center
  • Cleveland Clinic Foundation
  • University of Pennsylvania Health System
  • Main Line Health Heart Center
  • Vanderbilt Medical Center
  • Cardiothoracic and Vascular Surgeons
  • Baylor College of Medicine
  • Intermountain Medical Center
  • Aurora St. Luke's Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trifecta Aortic Heart Valve

Arm Description

All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.

Outcomes

Primary Outcome Measures

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]
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 16, 2007
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00475709
Brief Title
Aortic Valve Replacement With Trifecta(TM)
Official Title
An Observational, Prospective Evaluation of the Trifecta Valve
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To confirm the clinical safety and effectiveness of the Trifecta 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis
Keywords
aortic valve, heart valve, tissue valve, bioprosthesis, valve disorder, valve disease, cardiac surgery, aortic valve stenosis, aortic valve regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1022 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trifecta Aortic Heart Valve
Arm Type
Experimental
Arm Description
All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
Intervention Type
Device
Intervention Name(s)
Trifecta Aortic Heart Valve
Intervention Description
Surgical replacement of the aortic valve with the Trifecta Aortic Heart Valve.
Primary Outcome Measure Information:
Title
Late Adverse Event Rates
Description
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]
Time Frame
Events occurring greater than or equal to 31 days post-implant.
Title
Characterize Patient NYHA Functional Classification Status.
Description
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.
Time Frame
1 year
Title
Characterize the Hemodynamic Performance of the Valve.
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hartzell Schaff, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Keck School of Medicine, Dept. of Cardiothoracic Surgery, USC University Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Sarasota Memorial Hospital/Clinical Research Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
NYU Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Mission Hospitals
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Main Line Health Heart Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Cardiothoracic and Vascular Surgeons
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States

12. IPD Sharing Statement

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Aortic Valve Replacement With Trifecta(TM)

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