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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
Canada
Study Type
Interventional
Intervention
Trifecta aortic heart valve
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
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

  • University of British Columbia, St. Paul's Hospital
  • QEII Health Sciences Center
  • University Health Network - Toronto General Hospital
  • Montreal Heart Institute
  • Hôpital Laval

Outcomes

Primary Outcome Measures

Characterize patient NYHA functional classification status.
Characterize the hemodynamic performance of the valve.
Establish adverse event rates.

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
NCT00475267
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
May 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
The purpose of this study is 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
203 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Trifecta aortic heart valve
Intervention Description
Intended as a replacement for a diseased, damaged, or malfunctioning aortic heart valve.
Primary Outcome Measure Information:
Title
Characterize patient NYHA functional classification status.
Time Frame
At required follow-up intervals
Title
Characterize the hemodynamic performance of the valve.
Time Frame
At required follow-up intervals
Title
Establish adverse event rates.
Time Frame
Ongoing

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
University of British Columbia, St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
QEII Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
University Health Network - Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Hôpital Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
GN 4G5
Country
Canada

12. IPD Sharing Statement

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Aortic Valve Replacement With Trifecta(TM)

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