Trifecta™ GT Post Market Clinical Follow-up

February 7, 2025 updated by: Abbott Medical Devices

Trifecta™ GT (Glide Technology) Post Market Clinical Follow-up (PMCF)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
358

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Brussels - Capital Region
      • Brussels, Brussels - Capital Region, Belgium, 1200
        • Cliniques Universitaires Saint Luc
  • Canada
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L4L2
        • Saint John Regional Hospital - New Brunswick Heart Centre
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
    • Quebec
      • Montréal, Quebec, Canada, H1T 1C8
        • Institut de Cardiologie de Montreal
  • Estonia
      • Tartu, Estonia, 50406
        • Tartu University Hospital
  • France
    • Brittany
      • Rennes, Brittany, France, 35033
        • CHRU Hôpital de Pontchaillou
  • Germany
      • Berlin, Germany, 65760
        • Deutsches Herzzentrum Berlin
      • Hamburg, Germany, 21075
        • Asklepios Klinik Harburg
    • Hesse
      • Bad Nauheim, Hesse, Germany, 61231
        • Kerckhoff-Klinik gGmbH
    • Rhineland-Palatinate
      • Trier, Rhineland-Palatinate, Germany, 54292
        • Krankenhaus der Barmherzigen Brüder
    • Saxony
      • Leipzig, Saxony, Germany, 04289
        • Herzzentrum Leipzig GmbH
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Universitätsklinikum Jena
  • Italy
    • Lombardy
      • Milano, Lombardy, Italy, 20162
        • Ospedale Niguarda Ca'Granda
    • Tuscany
      • Firenze, Tuscany, Italy, 51034
        • Az. Osp Universitaria Careggi
    • Veneto
      • Mestre, Veneto, Italy, 30174
        • Ospedale dell'Angelo
  • Netherlands
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
        • Catharina Ziekenhuis
  • Poland
    • Mazovia
      • Warsaw, Mazovia, Poland, 02-507
        • Centralny Szpital Kliniczny MSW w Warszawie
  • Portugal
      • Porto, Portugal, 4202-451
        • Hospital de Sao Joao
  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03293
        • Hospital Universitario del Vinalopó
    • Balearic Island
      • Palma de Mallorca, Balearic Island, Spain, 07120
        • Hospital Universitario Son Espases
  • United Kingdom
      • London, United Kingdom, EC1A 7BE
        • St. Bartholomew's Hospital
    • South West England
      • Plymouth, South West England, United Kingdom, PL6 8DH
        • Plymouth Hospitals NHS Trust - Derriford Hospital
  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Health & Hospitals
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Main Line Health Center/Lankenau Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Centennial Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • CHI St. Luke's Health Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. Subject is of legal age in the country where the subject is enrolled.
  3. Subject must be willing and able to provide written informed consent to participate in this study.
  4. Subject must be willing and able to comply with all follow-up requirements.

Exclusion Criteria:

  1. Subject undergoes a concomitant procedure of mitral or tricuspid valve replacement at the time of the Trifecta GT valve implantation surgery.
  2. Subject has contraindication for cardiac surgery.
  3. Subject is pregnant. Pregnancy will be assessed by the subject informing the physicians.
  4. 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).
  5. Subject has had a stroke or transient ischemic attack within 6 months prior to the planned valve implantation surgery.
  6. Subject is undergoing renal dialysis.
  7. Subject has a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.
  8. Subject has a documented thrombus in the left atrium or left ventricle at the time of the valve implantation surgery.
  9. Subject has a left ventricular ejection fraction < 30%.
  10. Subject previously enrolled in the Trifecta GT PMCF study and withdrawn (a subject cannot be enrolled twice in this study).
  11. Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
  12. Subject has a life expectancy less than 2 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Treatment
All subjects will receive the Trifecta GT valve
Device: Trifecta GT (Glide Technology) Valve
Surgical aortic valve replacement with Trifecta GT Valve.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation
Time Frame: 5 years post implant
Estimated percentage of participants free from undergoing an additional aortic valve replacement within 5 years, using a Kaplan-Meier estimate.
5 years post implant

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Freedom From All-cause Mortality
Time Frame: 5 years post implant
Estimated percentage of participants surviving at 5 years, using a Kaplan-Meier estimate.
5 years post implant
Freedom From Valve Related Mortality
Time Frame: 5 years post implant
Estimated percentage of participants remaining free from a valve-related death at 5 years, using a Kaplan-Meier estimate. The estimate includes subjects alive at 5 years and subjects who died for reasons unrelated to the valve at 5 years.
5 years post implant
Freedom From Structural Valve Deterioration
Time Frame: 5 years post implant
Estimated percentage of participants free from structural valve deterioration at 5 years, as using a Kaplan-Meier estimate. Structural valve deterioration is any change in function of the valve resulting in an intrinsic abnormality of the valve that causes stenosis or regurgitation.
5 years post implant
Freedom From Surgical Valve Replacement or Transcatheter Valve Implantation Due to Structural Valve Deterioration
Time Frame: 5 years post implant
Estimated percentage of participants who do not require surgery due to structural valve deterioration, using a Kaplan-Meier estimate.
5 years post implant
Valve Hemodynamic Performance for Left Ventricular Ejection Fraction (LVEF) at Six Months
Time Frame: 6 Months
LVEF is a measurement of the percentage of blood leaving the heart each time it contracts.
6 Months
Valve Hemodynamic Performance for Effective Orifice Area (EOA) at Six Months
Time Frame: 6 Months
EOA measures the functional valve opening for blood flow through the valve.
6 Months
Valve Hemodynamic Performance for Indexed Effective Orifice Area (iEOA) at Six Months
Time Frame: 6 Months
iEOA adjusts the EOA measurement to the patient's body size.
6 Months
Valve Hemodynamic Performance for Mean Gradient at Six Months
Time Frame: 6 Months
Mean Gradient measures the average pressure difference across the valve during blood flow.
6 Months
Valve Hemodynamic Performance for Peak Gradient at Six Months
Time Frame: 6 Months
Peak Gradient measures the maximum pressure difference across the valve during blood flow.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Barathi Sethuraman, Abbott Structural Heart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SJM-CIP-10120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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