Trifecta™ GT Post Market Clinical Follow-up

NCT ID: NCT03016169

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 358 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-09
• Study Completion Date: 2023-08-31

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.

Conditions

Aortic Valve Disease; Aortic Valve Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

All subjects will receive the Trifecta GT valve

Group Type: OTHER

Trifecta GT (Glide Technology) Valve

Intervention Type: DEVICE

Surgical aortic valve replacement with Trifecta GT Valve.

Interventions

Trifecta GT (Glide Technology) Valve

Surgical aortic valve replacement with Trifecta GT Valve.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barathi Sethuraman

Role: STUDY_DIRECTOR

Abbott Structural Heart

Locations

Mayo Clinic

Rochester, Minnesota, United States

Mission Health & Hospitals

Asheville, North Carolina, United States

Main Line Health Center/Lankenau Hospital

Wynnewood, Pennsylvania, United States

Centennial Medical Center

Nashville, Tennessee, United States

CHI St. Luke's Health Baylor College of Medicine

Houston, Texas, United States

Cliniques Universitaires Saint Luc

Brussels, Brussels Capital, Belgium

Saint John Regional Hospital - New Brunswick Heart Centre

Saint John, New Brunswick, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Institut de Cardiologie de Montreal

Montreal, Quebec, Canada

Tartu University Hospital

Tartu, , Estonia

CHRU Hopital de Pontchaillou

Rennes, Brittany Region, France

Kerckhoff-Klinik gGmbH

Bad Nauheim, Hesse, Germany

Krankenhaus der Barmherzigen Brüder

Trier, Rhineland-Palatinate, Germany

Herzzentrum Leipzig GmbH

Leipzig, Saxony, Germany

Universitätsklinikum Jena

Jena, Thuringia, Germany

Deutsches Herzzentrum Berlin

Berlin, , Germany

Asklepios Klinik Harburg

Hamburg, , Germany

Ospedale Niguarda Ca'Granda

Milan, Lombardy, Italy

Az. Osp Universitaria Careggi

Florence, Tuscany, Italy

Ospedale dell'Angelo

Mestre, Veneto, Italy

Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

Centralny Szpital Kliniczny MSW w Warszawie

Warsaw, Masovian Voivodeship, Poland

Hospital de São João

Porto, , Portugal

Hospital Universitario del Vinalopó

Elche, Alicante, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Island, Spain

Plymouth Hospitals NHS Trust - Derriford Hospital

Plymouth, South West England, United Kingdom

St. Bartholomew's Hospital

London, , United Kingdom

Countries

United States; Belgium; Canada; Estonia; France; Germany; Italy; Netherlands; Poland; Portugal; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SJM-CIP-10120

Identifier Type: -

Identifier Source: org_study_id