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CompletedNCT03016169Updated Feb 11, 2025Results posted

Trifecta™ GT Post Market Clinical Follow-up

An interventional study of Trifecta GT (Glide Technology) Valve in Aortic Valve Disease and Aortic Valve Disorder, sponsored by Abbott Medical Devices. Completed at 27 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.

Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
358
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Aortic Valve Disease
  • Aortic Valve Disorder

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03

In context

Aortic Valve Disease

231 studies on the registry are indexed under Aortic Valve Disease; 76 are open to participants now.

This study's enrollment of 358 is above the median of 108 across 116 interventional studies indexed under Aortic Valve Disease.

Browse Aortic Valve Disease studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
358 participants (actual)

Study arms

  • Other
    Treatment

    All subjects will receive the Trifecta GT valve

    Device: Trifecta GT (Glide Technology) Valve

Interventions

  • DeviceTrifecta GT (Glide Technology) Valve

    Surgical aortic valve replacement with Trifecta GT Valve.

06

What researchers measure

Primary outcomes

  1. Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation

    Estimated percentage of participants free from undergoing an additional aortic valve replacement within 5 years, using a Kaplan-Meier estimate.

    Time frame: 5 years post implant

Other outcomes

  1. Freedom From All-cause Mortality

    Estimated percentage of participants surviving at 5 years, using a Kaplan-Meier estimate.

    Time frame: 5 years post implant

  2. Freedom From Valve Related Mortality

    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.

    Time frame: 5 years post implant

  3. Freedom From Structural Valve Deterioration

    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.

    Time frame: 5 years post implant

  4. Freedom From Surgical Valve Replacement or Transcatheter Valve Implantation Due to Structural Valve Deterioration

    Estimated percentage of participants who do not require surgery due to structural valve deterioration, using a Kaplan-Meier estimate.

    Time frame: 5 years post implant

  5. Valve Hemodynamic Performance for Left Ventricular Ejection Fraction (LVEF) at Six Months

    LVEF is a measurement of the percentage of blood leaving the heart each time it contracts.

    Time frame: 6 Months

  6. Valve Hemodynamic Performance for Effective Orifice Area (EOA) at Six Months

    EOA measures the functional valve opening for blood flow through the valve.

    Time frame: 6 Months

  7. Valve Hemodynamic Performance for Indexed Effective Orifice Area (iEOA) at Six Months

    iEOA adjusts the EOA measurement to the patient's body size.

    Time frame: 6 Months

  8. Valve Hemodynamic Performance for Mean Gradient at Six Months

    Mean Gradient measures the average pressure difference across the valve during blood flow.

    Time frame: 6 Months

  9. Valve Hemodynamic Performance for Peak Gradient at Six Months

    Peak Gradient measures the maximum pressure difference across the valve during blood flow.

    Time frame: 6 Months

07

Results

Posted May 29, 2024

Participant flow

A total of 358 subjects were enrolled across 27 investigational sites in 12 North American and European countries. The Trifecta GT PMCF study is a single-arm, prospective, multi-center clinical investigation designed to evaluate the five-year safety and performance of the Trifecta GT valve in patients indicated for aortic valve replacement.

Participant flow — Overall Study
MilestoneTreatment
Started358
Completed269
Not completed89
Withdrew: Lost to follow-up4
Withdrew: Death54
Withdrew: Device explant11
Withdrew: Withdrawal by subject19
Withdrew: Other reasons1

Outcome measures

PrimaryFreedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation

Estimated percentage of participants free from undergoing an additional aortic valve replacement within 5 years, using a Kaplan-Meier estimate.

Time frame:
5 years post implant
Reported as:
Number · percentage of participants
Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation
percentage of participantsTreatment
Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation95.8 (92.8 to 97.6)
Other pre-specifiedFreedom From All-cause Mortality

Estimated percentage of participants surviving at 5 years, using a Kaplan-Meier estimate.

Time frame:
5 years post implant
Reported as:
Number · percentage of participants
Freedom From All-cause Mortality
percentage of participantsTreatment
Freedom From All-cause Mortality84.5 (80.2 to 88.0)
Other pre-specifiedFreedom From Valve Related Mortality

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.

Time frame:
5 years post implant
Reported as:
Number · percentage of participants
Freedom From Valve Related Mortality
percentage of participantsTreatment
Freedom From Valve Related Mortality95.4 (92.3 to 97.2)
Other pre-specifiedFreedom From Structural Valve Deterioration

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.

Time frame:
5 years post implant
Reported as:
Number · percentage of participants
Freedom From Structural Valve Deterioration
percentage of participantsTreatment
Freedom From Structural Valve Deterioration96.2 (93.3 to 97.9)
Other pre-specifiedFreedom From Surgical Valve Replacement or Transcatheter Valve Implantation Due to Structural Valve Deterioration

Estimated percentage of participants who do not require surgery due to structural valve deterioration, using a Kaplan-Meier estimate.

Time frame:
5 years post implant
Reported as:
Number · percentage of participants
Freedom From Surgical Valve Replacement or Transcatheter Valve Implantation Due to Structural Valve Deterioration
percentage of participantsTreatment
Freedom From Surgical Valve Replacement or Transcatheter Valve Implantation Due to Structural Valve Deterioration98.2 (95.8 to 99.3)
Other pre-specifiedValve Hemodynamic Performance for Left Ventricular Ejection Fraction (LVEF) at Six Months

LVEF is a measurement of the percentage of blood leaving the heart each time it contracts.

Time frame:
6 Months
Reported as:
Mean · percentage
Valve Hemodynamic Performance for Left Ventricular Ejection Fraction (LVEF) at Six Months
percentageTreatment
Valve Hemodynamic Performance for Left Ventricular Ejection Fraction (LVEF) at Six Months60.4 ± 7.5
Other pre-specifiedValve Hemodynamic Performance for Effective Orifice Area (EOA) at Six Months

EOA measures the functional valve opening for blood flow through the valve.

Time frame:
6 Months
Reported as:
Mean · cm^2
Valve Hemodynamic Performance for Effective Orifice Area (EOA) at Six Months
cm^2Treatment
Valve Hemodynamic Performance for Effective Orifice Area (EOA) at Six Months2.0 ± 0.6
Other pre-specifiedValve Hemodynamic Performance for Indexed Effective Orifice Area (iEOA) at Six Months

iEOA adjusts the EOA measurement to the patient's body size.

Time frame:
6 Months
Reported as:
Mean · cm^2/m^2
Valve Hemodynamic Performance for Indexed Effective Orifice Area (iEOA) at Six Months
cm^2/m^2Treatment
Valve Hemodynamic Performance for Indexed Effective Orifice Area (iEOA) at Six Months1.0 ± 0.3
Other pre-specifiedValve Hemodynamic Performance for Mean Gradient at Six Months

Mean Gradient measures the average pressure difference across the valve during blood flow.

Time frame:
6 Months
Reported as:
Mean · mmHg
Valve Hemodynamic Performance for Mean Gradient at Six Months
mmHgTreatment
Valve Hemodynamic Performance for Mean Gradient at Six Months8.7 ± 3.3
Other pre-specifiedValve Hemodynamic Performance for Peak Gradient at Six Months

Peak Gradient measures the maximum pressure difference across the valve during blood flow.

Time frame:
6 Months
Reported as:
Mean · mmHg
Valve Hemodynamic Performance for Peak Gradient at Six Months
mmHgTreatment
Valve Hemodynamic Performance for Peak Gradient at Six Months16.6 ± 6.3

Adverse events

Collected over 5 Years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment54/358 (15.1%)206/358 (57.5%)82/358 (22.9%)
Most frequent serious events
Showing 10 of 55
Most frequent serious events
EventTreatment
OTHER CARDIOVASCULARCardiac disorders83/358
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULARInfections and infestations36/358
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULARRespiratory, thoracic and mediastinal disorders31/358
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULARNeoplasms benign, malignant and unspecified (incl cysts and polyps)26/358
OTHER NEUROVASCULARNervous system disorders20/358
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULARRenal and urinary disorders18/358
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULARGastrointestinal disorders17/358
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULARMusculoskeletal and connective tissue disorders16/358
OTHER CARDIOVASCULARBlood and lymphatic system disorders12/358
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULARGeneral disorders11/358
Most frequent other events
Showing 10 of 27
Most frequent other events
EventTreatment
OTHER CARDIOVASCULARCardiac disorders42/358
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULARRespiratory, thoracic and mediastinal disorders8/358
OTHER CARDIOVASCULARVascular disorders8/358
NONSTRUCTURAL DYSFUNCTIONCardiac disorders5/358
STRUCTURAL VALVE DETERIORATIONCardiac disorders4/358
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULARBlood and lymphatic system disorders3/358
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULARGastrointestinal disorders3/358
OTHER NEUROVASCULARNervous system disorders3/358
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULARSkin and subcutaneous tissue disorders3/358
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULARCardiac disorders2/358

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment
Mean70.8 ± 7.6
Sex: Female, Male
Sex: Female, Male(Participants)Treatment
Female140
Male218
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Treatment
Hypertension
Hypertension(Participants)Treatment
Count of participants291
08

Study locations

27 sites
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Mission Health & Hospitals
    Asheville, North Carolina 28801, United States
  • Main Line Health Center/Lankenau Hospital
    Wynnewood, Pennsylvania 19096, United States
  • Centennial Medical Center
    Nashville, Tennessee 37203, United States
  • CHI St. Luke's Health Baylor College of Medicine
    Houston, Texas 77030, United States
  • Cliniques Universitaires Saint Luc
    Brussels, Brussels - Capital Region 1200, Belgium
  • Saint John Regional Hospital - New Brunswick Heart Centre
    Saint John, New Brunswick E2L4L2, Canada
  • Toronto General Hospital
    Toronto, Ontario M5G 2C4, Canada
  • Institut de Cardiologie de Montreal
    Montréal, Quebec H1T 1C8, Canada
  • Tartu University Hospital
    Tartu, 50406, Estonia
  • CHRU Hopital de Pontchaillou
    Rennes, Brittany 35033, France
  • Kerckhoff-Klinik gGmbH
    Bad Nauheim, Hesse 61231, Germany
  • Krankenhaus der Barmherzigen Brüder
    Trier, Rhineland-Palatinate 54292, Germany
  • Herzzentrum Leipzig GmbH
    Leipzig, Saxony 04289, Germany
  • Universitätsklinikum Jena
    Jena, Thuringia 07747, Germany
  • Deutsches Herzzentrum Berlin
    Berlin, 65760, Germany
  • Asklepios Klinik Harburg
    Hamburg, 21075, Germany
  • Ospedale Niguarda Ca'Granda
    Milano, Lombardy 20162, Italy
  • Az. Osp Universitaria Careggi
    Firenze, Tuscany 51034, Italy
  • Ospedale dell'Angelo
    Mestre, Veneto 30174, Italy
  • Catharina Ziekenhuis
    Eindhoven, Noord-Brabant 5623 EJ, Netherlands
  • Centralny Szpital Kliniczny MSW w Warszawie
    Warsaw, Mazovia 02-507, Poland
  • Hospital de São João
    Porto, 4202-451, Portugal
  • Hospital Universitario del Vinalopó
    Elche, Alicante 03293, Spain
  • Hospital Universitario Son Espases
    Palma de Mallorca, Balearic Island 07120, Spain
  • Plymouth Hospitals NHS Trust - Derriford Hospital
    Plymouth, South West England PL6 8DH, United Kingdom
  • St. Bartholomew's Hospital
    London, EC1A 7BE, United Kingdom
09

References and documents

Study documents

  • Study protocol · May 15, 2018
  • Statistical analysis plan · Jun 10, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03016169
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Jan 10, 2017
Start date
Mar 9, 2017
Primary completion
Apr 25, 2023
Completion
Aug 31, 2023
Results posted
May 29, 2024
Last update
Feb 11, 2025

Study contacts

Barathi Sethuraman
study director · Abbott Structural Heart

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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