Trifecta™ GT Post Market Clinical Follow-up

Aortic Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03016169
• Other study ID #: SJM-CIP-10120
• Status: Completed
• Phase: N/A
• Start date: March 9, 2017
• Est. completion date: August 31, 2023

Study information

• Verified date: April 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: August 31, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Disorder

Intervention

Device:
• Trifecta GT (Glide Technology) Valve
Surgical aortic valve replacement with Trifecta GT Valve.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Brussels	Brussels - Capital Region
Canada	Institut de Cardiologie de Montreal	Montréal	Quebec
Canada	Saint John Regional Hospital - New Brunswick Heart Centre	Saint John	New Brunswick
Canada	Toronto General Hospital	Toronto	Ontario
Estonia	Tartu University Hospital	Tartu
France	CHRU Hopital de Pontchaillou	Rennes	Brittany
Germany	Kerckhoff-Klinik gGmbH	Bad Nauheim	Hesse
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Asklepios Klinik Harburg	Hamburg
Germany	Universitätsklinikum Jena	Jena	Thuringia
Germany	Herzzentrum Leipzig GmbH	Leipzig	Saxony
Germany	Krankenhaus der Barmherzigen Brüder	Trier	Rhineland-Palatinate
Italy	Az. Osp Universitaria Careggi	Firenze	Tuscany
Italy	Ospedale dell'Angelo	Mestre	Veneto
Italy	Ospedale Niguarda Ca'Granda	Milano	Lombardy
Netherlands	Catharina Ziekenhuis	Eindhoven	Noord-Brabant
Poland	Centralny Szpital Kliniczny MSW w Warszawie	Warsaw	Mazovia
Portugal	Hospital de São João	Porto
Spain	Hospital Universitario del Vinalopó	Elche	Alicante
Spain	Hospital Universitario Son Espases	Palma de Mallorca	Balearic Island
United Kingdom	St. Bartholomew's Hospital	London
United Kingdom	Plymouth Hospitals NHS Trust - Derriford Hospital	Plymouth	South West England
United States	Mission Health & Hospitals	Asheville	North Carolina
United States	CHI St. Luke's Health Baylor College of Medicine	Houston	Texas
United States	Centennial Medical Center	Nashville	Tennessee
United States	Mayo Clinic	Rochester	Minnesota
United States	Main Line Health Center/Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Freedom From All-cause Mortality	Estimated percentage of participants surviving at 5 years, using a Kaplan-Meier estimate.	5 years post implant
Other	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.	5 years post implant
Other	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.	5 years post implant
Other	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.	5 years post implant
Other	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.	6 Months
Other	Valve Hemodynamic Performance for Effective Orifice Area (EOA) at Six Months	EOA measures the functional valve opening for blood flow through the valve.	6 Months
Other	Valve Hemodynamic Performance for Indexed Effective Orifice Area (iEOA) at Six Months	iEOA adjusts the EOA measurement to the patient's body size.	6 Months
Other	Valve Hemodynamic Performance for Mean Gradient at Six Months	Mean Gradient measures the average pressure difference across the valve during blood flow.	6 Months
Other	Valve Hemodynamic Performance for Peak Gradient at Six Months	Peak Gradient measures the maximum pressure difference across the valve during blood flow.	6 Months
Primary	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