Aortic Valve Disease Clinical Trial
Official title:
Trifecta™ GT (Glide Technology) Post Market Clinical Follow-up (PMCF)
Verified date | April 2024 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 Subject previously enrolled in the Trifecta GT PMCF study and withdrawn (a subject cannot be enrolled twice in this study). 11.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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
United States, Belgium, Canada, Estonia, France, Germany, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom,
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 |
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