Actively Recruiting
A Study to Assess Safety and Effectiveness of the JenaValve Trilogy Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients With Aortic Regurgitation
Led by JenaValve Technology, Inc. · Updated on 2026-05-19
1016
Participants Needed
24
Research Sites
504 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of the JenaValve Trilogy Transcatheter Heart Valve (THV) System compared to traditional surgical aortic valve replacement (SAVR) in patients with clinically significant native aortic regurgitation. This study aims to show that the Trilogy THV system is not worse than SAVR for treating this condition, which involves the heart's aortic valve leaking and causing blood flow issues. Participants will be randomly assigned to one of two groups: one receiving Transcatheter Aortic Valve Replacement (TAVR) using the Trilogy THV System, and the other undergoing SAVR with commercially available surgical prosthetic valves. The study does not involve blinding, and both procedures are performed according to accepted medical guidelines. During the trial, participants will be monitored for outcomes such as overall survival, stroke occurrence, and unplanned cardiac hospitalizations at 12 months. Additional assessments include hospital stay length, heart function measured by echocardiography, heart rhythm changes, and questionnaires about heart failure symptoms at various time points up to 10 years. Follow-up visits will ensure ongoing safety and effectiveness evaluations throughout the study duration, which extends until February 2036.
CONDITIONS
Brief 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 with moderate to severe or severe native aortic regurgitation confirmed by imaging or evidence of heart damage from aortic regurgitation
- 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 attend all required follow-up visits
- Meets local legal minimum age for informed consent
You will not qualify if you...
- Moderate or less aortic regurgitation severity
- Life expectancy under 24 months due to non-cardiac conditions
- High surgical risk for valve replacement
- Refusal of surgical aortic valve replacement or blood transfusion
- Need for aortic valve repair or surgery other than replacement
- Connective tissue diseases requiring aortic root intervention
- Inability to have pre-procedure CT scan for valve sizing
- Significant mitral or tricuspid valve disease needing repair or replacement
- Allergies or contraindications to anticoagulant medications, nitinol, or contrast media
- Conditions preventing safe reoperation such as hostile chest or prior surgery complications
- Emergency surgery or valve replacement needed
- Cardiogenic shock or need for mechanical circulatory support
- Active infection or recent infective endocarditis
- Recent cardiac resynchronization therapy device implantation
- Severely reduced heart function (LVEF under 25%) or right ventricular dysfunction
- Severe liver disease or active liver conditions
- Advanced kidney disease or dialysis
- Severe pulmonary hypertension or chronic obstructive pulmonary disease
- Blood disorders or bleeding conditions
- Uncontrolled atrial fibrillation
- Recent heart attack or vascular interventions
- Recent stroke or transient ischemic attack
- Body mass index outside 20 to 50 kg/m2 range
- Participation in other cardiovascular investigational trials without completed follow-up
- Severe cognitive decline or inability to consent
- Pregnancy or intent to become pregnant during study
- Specific anatomical heart valve or artery issues preventing safe treatment
- Severe aortic stenosis or hypertrophic cardiomyopathy
- Presence of intracardiac masses or thrombus
- Complex coronary artery disease unsuitable for revascularization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Single procedure visit
Participants undergo either Transcatheter Aortic Valve Replacement (TAVR) using the Trilogy THV System or Surgical Aortic Valve Replacement (SAVR) with a bioprosthetic valve.
1 procedure visit (in-person)
Duration - Up to 12 months and extended monitoring for up to 10 years
Participants are monitored for safety and effectiveness outcomes including mortality, stroke, rehospitalization, and valve function.
Follow-up visits at 30 days, 6 months, 12 months, and annually up to 10 years
Trial Site Locations
Total: 24 locations
1
CPMC Sutter Health
Burlingame, California, United States, 94010
Actively Recruiting
2
Scripps Health
La Jolla, California, United States, 92037
Actively Recruiting
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
4
Los Robles Medical Center
Thousand Oaks, California, United States, 91360
Actively Recruiting
5
BayCare Health
Clearwater, Florida, United States, 33756
Actively Recruiting
6
HCA North Florida
Gainesville, Florida, United States, 32605
Actively Recruiting
7
Emory University Hospital
Atlanta, Georgia, United States, 30308
Actively Recruiting
8
Piedmont Healthcare
Atlanta, Georgia, United States, 30369
Actively Recruiting
9
Heart Care Centers of IL / Hinsdale Hospital
Chicago, Illinois, United States, 60521
Actively Recruiting
10
Ascension St. Vincent Heart Center
Carmel, Indiana, United States, 46290
Actively Recruiting
11
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02420
Actively Recruiting
12
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
13
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
14
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
15
Buffalo General Medical Center
Buffalo, New York, United States, 14203
Actively Recruiting
16
Cumc/Nyph
New York, New York, United States, 10032
Actively Recruiting
17
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
18
Ohio Health
Columbus, Ohio, United States, 43214
Actively Recruiting
19
Lankenau Institute for Medical Research
Philadelphia, Pennsylvania, United States, 19096
Actively Recruiting
20
Houston Methodist Research Institute
Houston, Texas, United States, 77030
Actively Recruiting
21
Baylor Scott & White Health
Plano, Texas, United States, 75074
Actively Recruiting
22
Intermountain Health
Murray, Utah, United States, 84111
Actively Recruiting
23
Intermountain Healthcare
Murray, Utah, United States, 84119
Actively Recruiting
24
Sentara Norfolk
Norfolk, Virginia, United States, 23507
Actively Recruiting
Research Team
D
Duane Pinto, MD MPH
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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