Actively Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Led by JenaValve Technology, Inc. · Updated on 2026-04-13
1016
Participants Needed
21
Research Sites
554 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical indication for aortic valve replacement for native valve predominant aortic regurgitation with moderate to severe or severe AR (Grade 63+) on echocardiography or cardiac MRI
- Candidate for transcatheter aortic valve replacement using the Trilogy THV system and surgical aortic valve replacement with a bioprosthetic valve
- Agreement from subject and physician to return for all post-procedure follow-up visits
- Meets local legal minimum age for providing informed consent
You will not qualify if you...
- Confirmed moderate (2+) or less aortic regurgitation severity
- Life expectancy under 24 months due to non-cardiac conditions
- High risk for surgical aortic valve replacement
- Refusal of surgical valve replacement or blood transfusion
- Selected for aortic valve repair or other aortic surgery
- Marfan syndrome or connective tissue disease needing aortic root replacement
- Unable to undergo pre-procedure CT scan for valve sizing
- Significant mitral or tricuspid valve disease requiring repair or replacement
- Known allergy or contraindication to anticoagulants, nitinol, or contrast media
- Conditions preventing safe reoperation such as hostile chest or prior surgery complications
- Need for emergency surgery or transcatheter valve replacement
- Cardiogenic shock or mechanical circulatory support requirement
- Ongoing infection or positive blood cultures within 6 weeks
- Recent cardiac resynchronization therapy device implantation
- Left ventricular ejection fraction below 25%
- Moderate to severe right ventricular dysfunction
- Severe liver disease or active liver disease
- Chronic kidney disease stage 4 or 5 or dialysis
- Severe pulmonary hypertension
- Severe chronic obstructive pulmonary disease with low lung function or oxygen need
- Blood disorders with low blood cell counts or anemia not corrected
- History of bleeding disorders or active gastrointestinal bleeding
- Contraindications to mechanical circulatory support
- Uncontrolled atrial fibrillation with high resting heart rate
- Recent myocardial infarction within 30 days
- Recent coronary or peripheral interventions within 30 days
- Symptomatic carotid or vertebral artery disease or recent treatment
- Prior stroke with significant disability
- Stroke or transient ischemic attack within 6 months
- Body mass index below 20 or above 50 kg/m2
- Current participation in another cardiovascular investigational trial
- Severe cognitive decline preventing consent or follow-up
- Other medical, social, or psychological conditions preventing protocol adherence
- Pregnancy or intent to become pregnant before study completion
- Anatomical exclusions including abnormal valve types, unsuitable annulus size, or arterial issues
- Severe aortic stenosis
- Untreated hypertrophic obstructive cardiomyopathy
- Intracardiac mass, vegetation, or thrombus without proper anticoagulation
- Complex coronary artery disease not suitable for revascularization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
CPMC Sutter Health
Burlingame, California, United States, 94010
Actively Recruiting
2
Scripps Health
La Jolla, California, United States, 92037
Actively Recruiting
3
Cedar-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
4
BayCare Health
Clearwater, Florida, United States, 33756
Actively Recruiting
5
HCA North Florida
Gainesville, Florida, United States, 32605
Actively Recruiting
6
Emory University Hospital
Atlanta, Georgia, United States, 30308
Actively Recruiting
7
Piedmont Healthcare
Atlanta, Georgia, United States, 30369
Actively Recruiting
8
Heart Care Centers of IL / Hinsdale Hospital
Chicago, Illinois, United States, 60521
Actively Recruiting
9
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02420
Actively Recruiting
10
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
12
Minneapolis Heart Institute Founcation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
13
Cumc/Nyph
New York, New York, United States, 10032
Actively Recruiting
14
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
15
Ohio Health
Columbus, Ohio, United States, 43214
Actively Recruiting
16
Lankenau Institute for Medical Research
Philadelphia, Pennsylvania, United States, 19096
Actively Recruiting
17
Houston Methodist Research Institute
Houston, Texas, United States, 77030
Actively Recruiting
18
Baylor Scott & White Health
Plano, Texas, United States, 75074
Actively Recruiting
19
Intermountain Health
Murray, Utah, United States, 84111
Actively Recruiting
20
Intermountain Healthcare
Murray, Utah, United States, 84119
Actively Recruiting
21
Sentara Norfolk
Norfolk, Virginia, United States, 23507
Actively Recruiting
Research Team
D
Duane Pinto, MD MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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