Aortic Valve DiseaseNCT03016169
Trifecta™ GT Post Market Clinical Follow-up
A study testing Trifecta GT (Glide Technology) Valve in people with Aortic Valve Disease and Aortic Valve Disorder, run by Abbott Medical Devices at 27 sites in 12 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Aortic Valve Disorder
- What is being tested?
- Trifecta GT (Glide Technology) Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 27 sitesin 12 countries
- Study dates
- 9 Mar 2017to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
27 sites in 12 countries.
27 sites in 12 countries
Germany6 sites
Kerckhoff-Klinik gGmbH
Bad Nauheim, Hesse, 61231
Deutsches Herzzentrum Berlin
Berlin, 65760
Asklepios Klinik Harburg
Hamburg, 21075
Universitätsklinikum Jena
Jena, Thuringia, 07747
Herzzentrum Leipzig GmbH
Leipzig, Saxony, 04289
Krankenhaus der Barmherzigen Brüder
Trier, Rhineland-Palatinate, 54292
United States5 sites
Mission Health & Hospitals
Asheville, North Carolina, 28801
CHI St. Luke's Health Baylor College of Medicine
Houston, Texas, 77030
Centennial Medical Center
Nashville, Tennessee, 37203
Mayo Clinic
Rochester, Minnesota, 55905
Main Line Health Center/Lankenau Hospital
Wynnewood, Pennsylvania, 19096
Canada3 sites
Institut de Cardiologie de Montreal
Montreal, Quebec, H1T 1C8
Saint John Regional Hospital - New Brunswick Heart Centre
Saint John, New Brunswick, E2L4L2
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Italy3 sites
Az. Osp Universitaria Careggi
Florence, Tuscany, 51034
Ospedale dell'Angelo
Mestre, Veneto, 30174
Ospedale Niguarda Ca'Granda
Milan, Lombardy, 20162
Spain2 sites
Hospital Universitario del Vinalopó
Elche, Alicante, 03293
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Island, 07120
United Kingdom2 sites
St. Bartholomew's Hospital
London, EC1A 7BE
Plymouth Hospitals NHS Trust - Derriford Hospital
Plymouth, South West England, PL6 8DH
Belgium1 site
Cliniques Universitaires Saint Luc
Brussels, Brussels Capital, 1200
Poland1 site
Centralny Szpital Kliniczny MSW w Warszawie
Warsaw, Masovian Voivodeship, 02-507
About this study
Official title: 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.
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.
- Conditions
- Aortic Valve Disease, Aortic Valve Disorder
- Being tested
- Trifecta GT (Glide Technology) Valve
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trifecta GT (Glide Technology) ValveDevice
Surgical aortic valve replacement with Trifecta GT Valve.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | All subjects will receive the Trifecta GT valve Receives: Device: Trifecta GT (Glide Technology) Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start9 Mar 2017
- Primary completion25 Apr 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barathi Sethuraman, Study director, Abbott Structural Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016169
- Sponsor's protocol ID
- SJM-CIP-10120
- Status last verified
- Feb 2025
- First submitted
- 21 Dec 2016
- Last updated
- 11 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trifecta™ GT (Glide Technology) Post Market Clinical Follow-up (PMCF)
- ClinicalTrials.gov ID
- NCT03016169
- Acronym / sponsor ID
- SJM-CIP-10120
- Conditions
- Aortic Valve Disease, Aortic Valve Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Posted 29 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: Trifecta GT (Glide Technology) ValveAll subjects will receive the Trifecta GT valve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trifecta GT (Glide Technology) ValveSurgical aortic valve replacement with Trifecta GT Valve. | Device | Treatment |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barathi Sethuraman study director
Abbott Structural Heart
27 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trifecta GT (Glide Technology) Valve in people with Aortic Valve Disease and Aortic Valve Disorder, run by Abbott Medical Devices at 27 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Germany, United States, Canada, Italy, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation (time frame: 5 years post implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.