ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Purpose
To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)
Conditions
- Aortic Regurgitation
- Aortic Valve Insufficiency
- Aortic Insufficiency
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Clinical indication for AVR for native valve predominant AR defined as: 1. Class I or II indication for AVR according to ACC/AHA or ESC/EACTS guidelines with moderate to severe or severe AR (Grade ≥3+) on transthoracic echocardiography, transesophageal echocardiography or cardiac MRI as assessed by the core laboratory OR 2. AR severity that remains indeterminate despite core laboratory review of all imaging including at least one advanced imaging modality (TEE or cardiac MRI) AND evidence of left ventricular damage* from AR with unanimous agreement from the local heart team, an independent clinical evaluation committee and the CRB that the symptomatic subject (NYHA II or greater) will benefit from SAVR for AR 2. The subject is a candidate for TAVR using the Trilogy THV system and SAVR using a commercially approved bioprosthetic heart valve 3. Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits 4. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
Exclusion Criteria
- Confirmed moderate (2+) or less AR severity by core laboratory evaluation 2. Estimated life expectancy of less than 24 months due to associated non- cardiac comorbid conditions 3. Subject is high-risk for SAVR as determined by the local heart team 4. Subject refuses SAVR as a treatment option 5. Subject refuses a blood transfusion 6. Subject is selected for aortic valve repair or aortic surgery 7. Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention 8. Subject unable to undergo pre-procedure CT scan analysis for annular sizing 9. Mitral or tricuspid disease, considered clinically significant, such that if randomized to surgery, repair or replacement would be expected. 10. Subject has a known hypersensitivity or contraindication to all anticoagulation/antiplatelet medications (or inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated 11. Hostile chest or conditions or complications from a prior surgery that would preclude safe reoperation (i.e., mediastinitis, radiation damage, chest wall abnormalities, adhesion of aorta or internal mammary artery (IMA) to the sternum) 12. Need for emergency surgery or TAVR for any reason 13. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or need for mechanical circulatory support 14. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks 15. Cardiac resynchronization therapy (CRT) device implantation within 30 days of randomization 16. LVEF <25% according to core laboratory measurement of resting echocardiogram at time of screening 17. Moderate to severe or worse right ventricular dysfunction on resting echocardiogram according to core laboratory 18. Severe chronic liver disease (Child-Pugh C) or any active liver disease 19. Chronic Kidney Disease Stage 4 or 5 (<30 cc/min/1.73 m2 or dialysis) 20. Severe Pulmonary Hypertension (pulmonary arterial systolic pressure - amp;amp;gt;2/3 systemic systolic pressure) 21. Severe Chronic Obstructive Pulmonary Disease (COPD) with FEV1 - amp;amp;lt;50% predicted or need for chronic supplementary oxygen 22. Blood dyscrasia as defined: leukopenia (WBC <3,000 Cells/μL), thrombocytopenia (platelet count <50,000 Cells/μL), or anemia (hemoglobin <9.0 g/dL) that is uncorrected prior to randomization 23. History of bleeding diathesis or coagulopathy that is not adequately treated 24. Active gastrointestinal bleeding precluding anticoagulation or antiplatelet therapy 25. Any condition considered a contraindication to mechanical circulatory support 26. Uncontrolled atrial fibrillation (i.e., resting heart rate >120 bpm) 27. Evidence of an acute myocardial infarction ≤30 days before the index AVR 28. Any percutaneous coronary or peripheral interventional procedure performed ≤30 days prior to AVR (Subjects with placement of coronary or peripheral stent(s) should be assessed for the ability to safely proceed with SAVR within the protocol timeframe) 29. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization 30. Prior stroke with residual modified Rankin Score ≥2 31. Stroke or transient ischemic attack (TIA) within 6 months of randomization 32. Body mass index (BMI) <20 or >50 kg/m2 33. Currently participating in a cardiovascular investigational drug or device trial and has not yet completed follow-up for the primary endpoint (excluding registries) 34. Severe cognitive decline (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits) 35. Other medical, social, or psychological conditions that in the opinion of the investigator preclude the subject from appropriate consent or adherence to the protocol required follow-up exams 36. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements 37. Anatomical exclusion criteria (ANY of the following): 1. Congenital bicuspid, unicuspid or quadricuspid aortic valve verified by echocardiography or CCT core laboratory 2. Native aortic annulus perimeter <66 mm or >90 mm per the core laboratory reading of baseline cardiac CT imaging 3. Iliofemoral arteries with vessel characteristics unsuitable for sheath passage (e.g., calcification, tortuosity) as determined by the case review board (CRB) 4. Significant abdominal or thoracic aortic disease (such as porcelain aorta, aneurysm, severe calcification, aortic coarctation) that would preclude safe passage of the delivery system or cannulation and aortotomy for SAVR 5. According to the CRB, a combination of aortic root angulation (angle between the plane of the aortic valve annulus and horizontal plane/vertebrae), sinus size, and straight length of the aorta that will not allow safe device delivery and THV deployment 6. Sinus of Valsalva anatomy that would prevent adequate coronary perfusion after valve implantation 38. According to core laboratory evaluation, severe aortic stenosis 39. Uncorrected hypertrophic obstructive cardiomyopathy 40. Echocardiographic or Multi-slice CT (MSCT) evidence of untreated intracardiac mass or vegetation 41. Left ventricular thrombus 42. Left atrial thrombus without continuous appropriate anticoagulation within 90 days of the study procedure 43. Complex coronary artery disease: 1. Unprotected left main coronary artery disease ≥50% 2. Syntax score >32 (in the absence of prior revascularization) 3. Heart Team determines that optimal revascularization cannot be adequately performed with EITHER CABG at the time of SAVR OR PCI at least 30 days prior to THV implant.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Transcatheter Aortic Valve Replacement (TAVR) |
Transcatheter Aortic Valve Replacement (TAVR) using the Trilogy THV System |
|
|
Other SAVR |
SAVR using commercially available surgical prosthetic valve |
|
Recruiting Locations
CPMC Sutter Health
Burlingame 5331920, California 5332921 94010
Burlingame 5331920, California 5332921 94010
Scripps Health
La Jolla 5363943, California 5332921 92037
La Jolla 5363943, California 5332921 92037
Cedar-Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
Los Angeles 5368361, California 5332921 90048
BayCare Health
Clearwater 4151316, Florida 4155751 33756
Clearwater 4151316, Florida 4155751 33756
HCA North Florida
Gainesville 4156404, Florida 4155751 32605
Gainesville 4156404, Florida 4155751 32605
Emory University Hospital
Atlanta 4180439, Georgia 4197000 30308
Atlanta 4180439, Georgia 4197000 30308
Piedmont Healthcare
Atlanta 4180439, Georgia 4197000 30369
Atlanta 4180439, Georgia 4197000 30369
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02420
Boston 4930956, Massachusetts 6254926 02420
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
Ann Arbor 4984247, Michigan 5001836 48109
Henry Ford Health
Detroit 4990729, Michigan 5001836 48202
Detroit 4990729, Michigan 5001836 48202
Minneapolis Heart Institute Founcation
Minneapolis 5037649, Minnesota 5037779 55407
Minneapolis 5037649, Minnesota 5037779 55407
Cumc/Nyph
New York 5128581, New York 5128638 10032
New York 5128581, New York 5128638 10032
The Christ Hospital
Cincinnati 4508722, Ohio 5165418 45219
Cincinnati 4508722, Ohio 5165418 45219
Ohio Health
Columbus 4509177, Ohio 5165418 43214
Columbus 4509177, Ohio 5165418 43214
Houston Methodist Research Institute
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Baylor Scott & White Health
Plano 4719457, Texas 4736286 75074
Plano 4719457, Texas 4736286 75074
Intermountain Health
Murray 5778755, Utah 5549030 84111
Murray 5778755, Utah 5549030 84111
Intermountain Healthcare
Murray 5778755, Utah 5549030 84119
Murray 5778755, Utah 5549030 84119
Sentara Norfolk
Norfolk 4776222, Virginia 6254928 23507
Norfolk 4776222, Virginia 6254928 23507
More Details
- Status
- Recruiting
- Sponsor
- JenaValve Technology, Inc.