search
Back to results

Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve

Primary Purpose

Heart Valve Diseases

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

About this trial

This is an interventional treatment trial for Heart Valve Diseases focused on measuring Trifecta Valve

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects implanted with a Trifecta valve at one of the US sites of the IDE study.
  • Subject met eligibility criteria of IDE study
  • Subject agrees to complete study follow-up visits
  • Subject provides written informed consent

Exclusion Criteria:

  • Subject currently participating in another device or drug study
  • Subject unable or unwilling to return for study follow-up visits

Sites / Locations

  • Abbott Northwestern Hospital Cardiac Surgical Associates
  • Mayo Clinic
  • Mission Hospital
  • Hospital of the University of Pennsylvania
  • Vanderbilt Heart Institute
  • Intermountain Heart & Lung Surgical Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trifecta Valve Group

Arm Description

Subjects implanted with a Trifecta valve.

Outcomes

Primary Outcome Measures

Late Adverse Event Incidence
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]

Secondary Outcome Measures

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.
Report 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.

Full Information

First Posted
January 17, 2012
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
search

1. Study Identification

Unique Protocol Identification Number
NCT01514162
Brief Title
Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
Official Title
Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve
Detailed Description
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in subjects who had a Trifecta valve implanted during the IDE study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases
Keywords
Trifecta Valve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trifecta Valve Group
Arm Type
Experimental
Arm Description
Subjects implanted with a Trifecta valve.
Intervention Type
Device
Intervention Name(s)
Trifecta valve
Intervention Description
surgical replacement of aortic valve
Primary Outcome Measure Information:
Title
Late Adverse Event Incidence
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
5 years
Secondary Outcome Measure Information:
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
5 years
Title
Report 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
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects implanted with a Trifecta valve at one of the US sites of the IDE study. Subject met eligibility criteria of IDE study Subject agrees to complete study follow-up visits Subject provides written informed consent Exclusion Criteria: Subject currently participating in another device or drug study Subject unable or unwilling to return for study follow-up visits
Facility Information:
Facility Name
Abbott Northwestern Hospital Cardiac Surgical Associates
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
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt Heart Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Intermountain Heart & Lung Surgical Associates
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve

We'll reach out to this number within 24 hrs