Clinical trial NCT03016169: Trifecta™ GT Post Market Clinical Follow-up
Official title: Trifecta™ GT (Glide Technology) Post Market Clinical Follow-up (PMCF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Disease
Aortic Valve Disorder
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2017-01-10
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation
timeFrame: 5 years post implant
Secondary outcomes:
Other outcomes:
measure: Freedom From All-cause Mortality
timeFrame: 5 years post implant
measure: Freedom From Valve Related Mortality
timeFrame: 5 years post implant
measure: Freedom From Structural Valve Deterioration
timeFrame: 5 years post implant
measure: Freedom From Surgical Valve Replacement or Transcatheter Valve Implantation Due to Structural Valve Deterioration
timeFrame: 5 years post implant
measure: Valve Hemodynamic Performance for Left Ventricular Ejection Fraction (LVEF) at Six Months
timeFrame: 6 Months
measure: Valve Hemodynamic Performance for Effective Orifice Area (EOA) at Six Months
timeFrame: 6 Months
measure: Valve Hemodynamic Performance for Indexed Effective Orifice Area (iEOA) at Six Months
timeFrame: 6 Months
measure: Valve Hemodynamic Performance for Mean Gradient at Six Months
timeFrame: 6 Months
measure: Valve Hemodynamic Performance for Peak Gradient at Six Months
timeFrame: 6 Months
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Asheville
country: United States
facility: Mission Health & Hospitals
state: North Carolina
city: Wynnewood
country: United States
facility: Main Line Health Center/Lankenau Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Houston
country: United States
facility: CHI St. Luke's Health Baylor College of Medicine
state: Texas
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
state: Brussels - Capital Region
city: Saint John
country: Canada
facility: Saint John Regional Hospital - New Brunswick Heart Centre
state: New Brunswick
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montréal
country: Canada
facility: Institut de Cardiologie de Montreal
state: Quebec
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Rennes
country: France
facility: CHRU Hopital de Pontchaillou
state: Brittany
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik gGmbH
state: Hesse
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
state: Rhineland-Palatinate
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
state: Saxony
city: Jena
country: Germany
facility: Universitätsklinikum Jena
state: Thuringia
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg
city: Milano
country: Italy
facility: Ospedale Niguarda Ca'Granda
state: Lombardy
city: Firenze
country: Italy
facility: Az. Osp Universitaria Careggi
state: Tuscany
city: Mestre
country: Italy
facility: Ospedale dell'Angelo
state: Veneto
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Noord-Brabant
city: Warsaw
country: Poland
facility: Centralny Szpital Kliniczny MSW w Warszawie
state: Mazovia
city: Porto
country: Portugal
facility: Hospital de São João
city: Elche
country: Spain
facility: Hospital Universitario del Vinalopó
state: Alicante
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Balearic Island
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust - Derriford Hospital
state: South West England
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
Study officials:
affiliation: Abbott Structural Heart
name: Barathi Sethuraman
role: STUDY_DIRECTOR
References: