NCT03016169

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
358

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
11 countries

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 9, 2017

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
9 months until next milestone

Results Posted

Study results publicly available

May 29, 2024

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

6.1 years

First QC Date

December 21, 2016

Results QC Date

March 5, 2024

Last Update Submit

February 7, 2025

Conditions

Aortic Valve DiseaseAortic Valve Disorder

Outcome Measures

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.

    5 years post implant

Other Outcomes (9)

  • Freedom From All-cause Mortality

    5 years post implant

  • Freedom From Valve Related Mortality

    5 years post implant

  • Freedom From Structural Valve Deterioration

    5 years post implant

  • +6 more other outcomes

Study Arms (1)

Treatment

OTHER

All subjects will receive the Trifecta GT valve

Device: Trifecta GT (Glide Technology) Valve

Interventions

Trifecta GT (Glide Technology) ValveDEVICE

Surgical aortic valve replacement with Trifecta GT Valve.

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mission Health & Hospitals

Asheville, North Carolina, 28801, United States

Location

Main Line Health Center/Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

CHI St. Luke's Health Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Cliniques Universitaires Saint Luc

Brussels, Brussels Capital, 1200, Belgium

Location

Saint John Regional Hospital - New Brunswick Heart Centre

Saint John, New Brunswick, E2L4L2, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Institut de Cardiologie de Montreal

Montreal, Quebec, H1T 1C8, Canada

Location

Tartu University Hospital

Tartu, 50406, Estonia

Location

CHRU Hopital de Pontchaillou

Rennes, Brittany Region, 35033, France

Location

Kerckhoff-Klinik gGmbH

Bad Nauheim, Hesse, 61231, Germany

Location

Krankenhaus der Barmherzigen Brüder

Trier, Rhineland-Palatinate, 54292, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, Saxony, 04289, Germany

Location

Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, 65760, Germany

Location

Asklepios Klinik Harburg

Hamburg, 21075, Germany

Location

Ospedale Niguarda Ca'Granda

Milan, Lombardy, 20162, Italy

Location

Az. Osp Universitaria Careggi

Florence, Tuscany, 51034, Italy

Location

Ospedale dell'Angelo

Mestre, Veneto, 30174, Italy

Location

Catharina Ziekenhuis

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Centralny Szpital Kliniczny MSW w Warszawie

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Hospital de São João

Porto, 4202-451, Portugal

Location

Hospital Universitario del Vinalopó

Elche, Alicante, 03293, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Island, 07120, Spain

Location

Plymouth Hospitals NHS Trust - Derriford Hospital

Plymouth, South West England, PL6 8DH, United Kingdom

Location

St. Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Karine Miquel, Associate Director of Project Management
Organization
Abbott
karine.miquel@abbott.com
+32 479 600 107

Study Officials

  • Barathi Sethuraman

    Abbott Structural Heart

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

January 10, 2017

Study Start

March 9, 2017

Primary Completion

April 25, 2023

Study Completion

August 31, 2023

Last Updated

February 11, 2025

Results First Posted

May 29, 2024

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)BE(1)ES(2)GB(2)IT(3)US(5)PT(1)CA(3)PL(1)FR(1)DE(6)