Trifecta™ GT Post Market Clinical Follow-up
Primary Purpose
Aortic Valve Disease, Aortic Valve Disorder
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Trifecta GT (Glide Technology) Valve
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Disease
Eligibility Criteria
Inclusion Criteria:
- Subject is a candidate for surgical aortic valve replacement per current guidelines and is intended to be implanted with a St. Jude Medical Trifecta GT valve.
- Subject is of legal age in the country where the subject is enrolled.
- Subject must be willing and able to provide written informed consent to participate in this study.
- Subject must be willing and able to comply with all follow-up requirements.
Exclusion Criteria:
- Subject undergoes a concomitant procedure of mitral or tricuspid valve replacement at the time of the Trifecta GT valve implantation surgery.
- Subject has contraindication for cardiac surgery.
- Subject is pregnant. Pregnancy will be assessed by the subject informing the physicians.
- Subject has active endocarditis (subjects who have previously experienced endocarditis must have two documented negative blood culture results while off antibiotic therapy prior to the valve implantation surgery).
- Subject has had a stroke or transient ischemic attack within 6 months prior to the planned valve implantation surgery.
- Subject is undergoing renal dialysis.
- Subject has a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.
- Subject has a documented thrombus in the left atrium or left ventricle at the time of the valve implantation surgery.
- Subject has a left ventricular ejection fraction < 30%.
- Subject previously enrolled in the Trifecta GT PMCF study and withdrawn (a subject cannot be enrolled twice in this study).
- Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
- Subject has a life expectancy less than 2 years.
Sites / Locations
- Mayo Clinic
- Mission Health & Hospitals
- Main Line Health Center/Lankenau Hospital
- Centennial Medical Center
- CHI St. Luke's Health Baylor College of Medicine
- Cliniques Universitaires Saint Luc
- Saint John Regional Hospital - New Brunswick Heart Centre
- Toronto General Hospital
- Institut de Cardiologie de Montreal
- Tartu University Hospital
- CHRU Hopital de Pontchaillou
- Kerckhoff-Klinik gGmbH
- Krankenhaus der Barmherzigen Brüder
- Herzzentrum Leipzig GmbH
- Universitätsklinikum Jena
- Deutsches Herzzentrum Berlin
- Asklepios Klinik Harburg
- Ospedale Niguarda Ca'Granda
- Az. Osp Universitaria Careggi
- Ospedale dell'Angelo
- Catharina Ziekenhuis
- Centralny Szpital Kliniczny MSW w Warszawie
- Hospital de São João
- Hospital Universitario del Vinalopó
- Hospital Universitario Son Espases
- Plymouth Hospitals NHS Trust - Derriford Hospital
- St. Bartholomew's Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment
Arm Description
All subjects will receive the Trifecta GT valve
Outcomes
Primary Outcome Measures
Freedom from surgical valve replacement or transcatheter valve-in-valve implantation
Determined by adverse event reporting
Secondary Outcome Measures
Full Information
NCT ID
NCT03016169
First Posted
December 21, 2016
Last Updated
October 23, 2023
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT03016169
Brief Title
Trifecta™ GT Post Market Clinical Follow-up
Official Title
Trifecta™ GT (Glide Technology) Post Market Clinical Follow-up (PMCF)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 9, 2017 (Actual)
Primary Completion Date
April 25, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the safety and performance of the Trifecta™ GT (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.
Detailed Description
The study is a prospective multi-center evaluation of approximately 350 subjects implanted with a St. Jude Medical (SJM) Trifecta™ GT valve. It will be conducted in approximately 35 sites worldwide.
Subjects will be followed for 5 years. The total duration of the study is expected to be 6 years, assuming all subjects are enrolled within 1 year of study initiation. To ensure enrollment balance across sites, no individual site can enroll more than 10% of the sample size (n=35 subjects) without prior approval from the sponsor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease, Aortic Valve Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
363 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Other
Arm Description
All subjects will receive the Trifecta GT valve
Intervention Type
Device
Intervention Name(s)
Trifecta GT (Glide Technology) Valve
Intervention Description
Surgical aortic valve replacement with Trifecta GT Valve.
Primary Outcome Measure Information:
Title
Freedom from surgical valve replacement or transcatheter valve-in-valve implantation
Description
Determined by adverse event reporting
Time Frame
5 years post implant
Other Pre-specified Outcome Measures:
Title
Freedom from all-cause mortality
Description
Determined by adverse event reporting
Time Frame
5 years post implant
Title
Freedom from valve related mortality
Description
Determined by adverse event reporting
Time Frame
5 years post implant
Title
Freedom from structural valve deterioration
Description
Determined by adverse event reporting
Time Frame
5 years post implant
Title
Freedom from surgical valve replacement or transcatheter valve implantation due to structural valve deterioration
Description
Determined by adverse event reporting
Time Frame
5 years post implant
Title
Valve hemodynamic performance
Description
Measured by echocardiogram
Time Frame
Up to 7 days, 6 months, 3 years and 5 years post implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is a candidate for surgical aortic valve replacement per current guidelines and is intended to be implanted with a St. Jude Medical Trifecta GT valve.
Subject is of legal age in the country where the subject is enrolled.
Subject must be willing and able to provide written informed consent to participate in this study.
Subject must be willing and able to comply with all follow-up requirements.
Exclusion Criteria:
Subject undergoes a concomitant procedure of mitral or tricuspid valve replacement at the time of the Trifecta GT valve implantation surgery.
Subject has contraindication for cardiac surgery.
Subject is pregnant. Pregnancy will be assessed by the subject informing the physicians.
Subject has active endocarditis (subjects who have previously experienced endocarditis must have two documented negative blood culture results while off antibiotic therapy prior to the valve implantation surgery).
Subject has had a stroke or transient ischemic attack within 6 months prior to the planned valve implantation surgery.
Subject is undergoing renal dialysis.
Subject has a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.
Subject has a documented thrombus in the left atrium or left ventricle at the time of the valve implantation surgery.
Subject has a left ventricular ejection fraction < 30%.
Subject previously enrolled in the Trifecta GT PMCF study and withdrawn (a subject cannot be enrolled twice in this study).
Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
Subject has a life expectancy less than 2 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinny Podichetty
Organizational Affiliation
Abbott Structural Heart
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mission Health & Hospitals
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Main Line Health Center/Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
CHI St. Luke's Health Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
State/Province
Brussels - Capital Region
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Saint John Regional Hospital - New Brunswick Heart Centre
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L4L2
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Institut de Cardiologie de Montreal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
CHRU Hopital de Pontchaillou
City
Rennes
State/Province
Brittany
ZIP/Postal Code
35033
Country
France
Facility Name
Kerckhoff-Klinik gGmbH
City
Bad Nauheim
State/Province
Hesse
ZIP/Postal Code
61231
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brüder
City
Trier
State/Province
Rhineland-Palatinate
ZIP/Postal Code
54292
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04289
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07747
Country
Germany
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
ZIP/Postal Code
65760
Country
Germany
Facility Name
Asklepios Klinik Harburg
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Ospedale Niguarda Ca'Granda
City
Milano
State/Province
Lombardy
ZIP/Postal Code
20162
Country
Italy
Facility Name
Az. Osp Universitaria Careggi
City
Firenze
State/Province
Tuscany
ZIP/Postal Code
51034
Country
Italy
Facility Name
Ospedale dell'Angelo
City
Mestre
State/Province
Veneto
ZIP/Postal Code
30174
Country
Italy
Facility Name
Catharina Ziekenhuis
City
Eindhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Centralny Szpital Kliniczny MSW w Warszawie
City
Warsaw
State/Province
Mazovia
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Hospital de São João
City
Porto
ZIP/Postal Code
4202-451
Country
Portugal
Facility Name
Hospital Universitario del Vinalopó
City
Elche
State/Province
Alicante
ZIP/Postal Code
03293
Country
Spain
Facility Name
Hospital Universitario Son Espases
City
Palma de Mallorca
State/Province
Balearic Island
ZIP/Postal Code
07120
Country
Spain
Facility Name
Plymouth Hospitals NHS Trust - Derriford Hospital
City
Plymouth
State/Province
South West England
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
St. Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Trifecta™ GT Post Market Clinical Follow-up
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