Aortic RegurgitationARTISTNCT06608823
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
A study testing Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System and SAVR in people with Aortic Regurgitation and Aortic Valve Insufficiency, run by JenaValve Technology, Inc. at 34 sites in United States.
Trial summary
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) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
- What is being tested?
- Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System and SAVR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,016 participants
- Where
- 34 sitesUnited States
- Study dates
- 18 Jun 2025to Feb 2036
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical indication for AVR for native valve predominant AR defined as:
- 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
- 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
- The subject is a candidate for TAVR using the Trilogy THV system and SAVR using a commercially approved bioprosthetic heart valve
- Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
- Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
Who cannot join
- Confirmed moderate (2+) or less AR severity by core laboratory evaluation
- Estimated life expectancy of less than 24 months due to associated non- cardiac comorbid conditions
- Subject is high-risk for SAVR as determined by the local heart team
- Subject refuses SAVR as a treatment option
- Subject refuses a blood transfusion
- Subject is selected for aortic valve repair or aortic surgery
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- Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention
- Subject unable to undergo pre-procedure CT scan analysis for annular sizing
- Mitral or tricuspid disease, considered clinically significant, such that if randomized to surgery, repair or replacement would be expected.
- 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
- 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)
- Need for emergency surgery or TAVR for any reason
- Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or need for mechanical circulatory support
- Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks
- Cardiac resynchronization therapy (CRT) device implantation within 30 days of randomization
- LVEF \<25% according to core laboratory measurement of resting echocardiogram at time of screening
- Moderate to severe or worse right ventricular dysfunction on resting echocardiogram according to core laboratory
- Severe chronic liver disease (Child-Pugh C) or any active liver disease
- Chronic Kidney Disease Stage 4 or 5 (\<30 cc/min/1.73 m2 or dialysis)
- Severe Pulmonary Hypertension (pulmonary arterial systolic pressure
- amp;amp;gt;2/3 systemic systolic pressure)
- Severe Chronic Obstructive Pulmonary Disease (COPD) with FEV1
- amp;amp;lt;50% predicted or need for chronic supplementary oxygen
- 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
- History of bleeding diathesis or coagulopathy that is not adequately treated
- Active gastrointestinal bleeding precluding anticoagulation or antiplatelet therapy
- Any condition considered a contraindication to mechanical circulatory support
- Uncontrolled atrial fibrillation (i.e., resting heart rate \>120 bpm)
- Evidence of an acute myocardial infarction ≤30 days before the index AVR
- 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)
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization
- Prior stroke with residual modified Rankin Score ≥2
- Stroke or transient ischemic attack (TIA) within 6 months of randomization
- Body mass index (BMI) \<20 or \>50 kg/m2
- Currently participating in a cardiovascular investigational drug or device trial and has not yet completed follow-up for the primary endpoint (excluding registries)
- 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)
- 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
- Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements
- Anatomical exclusion criteria (ANY of the following):
- Congenital bicuspid, unicuspid or quadricuspid aortic valve verified by echocardiography or CCT core laboratory
- Native aortic annulus perimeter \<66 mm or \>90 mm per the core laboratory reading of baseline cardiac CT imaging
- Iliofemoral arteries with vessel characteristics unsuitable for sheath passage (e.g., calcification, tortuosity) as determined by the case review board (CRB)
- 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
- 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
- Sinus of Valsalva anatomy that would prevent adequate coronary perfusion after valve implantation
- According to core laboratory evaluation, severe aortic stenosis
- Uncorrected hypertrophic obstructive cardiomyopathy
- Echocardiographic or Multi-slice CT (MSCT) evidence of untreated intracardiac mass or vegetation
- Left ventricular thrombus
- Left atrial thrombus without continuous appropriate anticoagulation within 90 days of the study procedure
- Complex coronary artery disease:
- Unprotected left main coronary artery disease ≥50%
- Syntax score \>32 (in the absence of prior revascularization)
- 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.
Trial locations and contacts
34 sites in 1 country. Contact the study team or a site near you to ask about taking part.
34 sites in 1 country
United States34 sites, 34 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Kasey Boyd, 732-232-4054, kzadoroz@med.umich.edu
Allison Schley, schleya@med.umich.edu
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30308
Elizabeth Charles, 404-686-1249, elizabeth.z.charles@emory.edu
Adam Greenbaum, MD
- Recruiting
Piedmont Healthcare
Atlanta, Georgia, 30369
Patrice Harris, 404-605-2327, Patrice.harris@piedmont.org
Pradeep Yadav, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Lina Fu, RN, 617-643-1371, lfu2@mgh.harvard.edu
Ignacio Inglessis-Azuaje, MD
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02420
Jen Kaufman, 617-632-8956, jmkaufma@bidmc.harvard.edu
Gabriella Urbano, 617-632-8956, gurbano@bidmc.harvard.edu
- Recruiting
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Lout Lewis, 609-893-1200 ext. 5022, LewisL@Deborah.org
Muhammad Raza, MD
- Recruiting
Buffalo General Medical Center
Buffalo, New York, 14203
Cassandra Davern, 716-881-8299, cadavern@buffalo.edu
Courtney Bishop, (716) 888-4859, cabishop@buffalo.edu
- Recruiting
CPMC Sutter Health
Burlingame, California, 94010
Milena Ferreira, 415-600-5707, Milena.Ferreira@sutterhealth.org
Sarah Hoffman, 415-600-0885, Sarah.Hoffman2@sutterhealth.org
- Recruiting
Ascension St. Vincent Heart Center
Carmel, Indiana, 46290
Jena Stanley, RN, 317-583-6115, jena.stanley@ascension.org
Cari Fekete, cari.fekete@ascension.org
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Virginia Theodorof, 843-876-9078, theodoro@musc.edu
Nicholas Amoroso, MD
- Recruiting
Heart Care Centers of IL / Hinsdale Hospital
Chicago, Illinois, 60521
Courtney Montgomery, 773-724-1249, cmontgomery@heartcc.com
Ravi Ramana, DO
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
Rachel Rogell, 513-585-2168, Rachel.Rogell@thechristhospital.com
Amanda Sears, Amanda.Sears@thechristhospital.com
- Recruiting
BayCare Health
Clearwater, Florida, 33756
Beth Schelle, RN, 727-462-2152, Mary.Schelle@baycare.org
Joshua Rovin, MD
- Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Emily Tylicki, RN, BSN, 216-444-6950, tylicke@ccf.org
Amar Krishnaswamy, MD
- Recruiting
Ohio Health
Columbus, Ohio, 43214
Katy Monnin, 614-566-1250, Katy.monnin@ohiohealth.com
Carlos Sanchez, MD
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Danielle Holmes, 313-916-3559, dholmes7@hfhs.org
Sara Poggio, 313-916-0119, Spoggio1@hfhs.org
- Recruiting
HCA North Florida
Gainesville, Florida, 32605
Danielle E Murrhee, 352-375-1212 ext. 1338, demurhee@tcavi.com
Brandy Baudon, 352.375.1212 ext. 1367, Bbaudoin@tcavi.com
- Recruiting
Houston Methodist Research Institute
Houston, Texas, 77030
Yejide Oyewole, RN, 346-238-2294, yoyewole@houstonmethodist.org
Melissa Alanis, RN, imalanis@houstonmethodist.org
- Recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64131
Diane Peterman, RN, 816-932-5989, diane.peterman@bjc.org
Stacy Sedler, RN, stacy.sedler@bjc.org
- Recruiting
Scripps Health
La Jolla, California, 92037
Alison Walton, 858-824-5461, Walton.Alison@Scrippshealth.org
Sophia Graham, 858-824-5271, Graham.Sophia@Scrippshealth.org
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Khaled Alsabaawi, 310-423-6226, khaled.Alsabaawi@cshs.org
m Gheorghiu, 310-407-9553, mitch.gheorghiu@cshs.org
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Nikki Degeneffe, 612-863-6286, Nicole.degeneffe@allina.com
Katelyn Swanson, 612.863.3974, Katelyn.swanson@allina.com
- Recruiting
Intermountain Health
Murray, Utah, 84107
McKenna Jensen, 801-507-4762, McKenna.Jensen@imail.com
Brian Whisenant, MD
- Recruiting
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Christopher Stradford, 732-235-9215, css165@rwjms.rutgers.edu
Mark Russo, MD
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Rose Adelman, 917-789-3945, rca2152@cumc.columbia.edu
Kerianne Nordland, 631-662-1256, kn2600@cumc.columbia.edu
- Recruiting
Sentara Norfolk
Norfolk, Virginia, 23507
Tina Calayo, 757-388-3876, cacalayo@sentara.com
Matthew Summers, MD
- Recruiting
Lankenau Institute for Medical Research
Philadelphia, Pennsylvania, 19096
Clare DeCamp, RN, 484-476-8426, DeCampC@mlhs.org
Diane Alonso, (484) 476-8520, alonsodi@mlhs.org
- Recruiting
Baylor Scott & White Health
Plano, Texas, 75074
Jenna Nimprasert, 469-814-4892, Jenna.Nimprasert@BSWHealth.org
Angela Mendez, 214-820-7358, Angela.mendez@BSWHealth.org
- Recruiting
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Zachary Taylor, 503-494-7443, taylorza@ohsu.edu
Harsh Golwala, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Kati Bargfrede, 507-422-0004, Bargfrede.Kathryn@mayo.edu
Kimberly A. Holst, MD
- Recruiting
University of Washington
Seattle, Washington, 98195
Joseph Oleksiak, 206-616-3541, oleksiak@uw.edu
Scott DeRoo, MD
- Recruiting
Washington University - Barnes Jewish Hospital
St Louis, Missouri, 63110
Kyle Stumbaugh, 314-747-0707, Kyles@wustl.edu
Alan Zajarias, MD
- Recruiting
Los Robles Medical Center
Thousand Oaks, California, 91360
Mane Arabyan, 615-979-7548, mane.arabyan@hcahealthcare.com
Saibal Kar, MD
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Kate Ellerd, 202-877-2806, katherine.a.ellerd@medstar.net
Erin Collins, 202-877-6622, Erin.C.Collins@medstar.net
About this study
Official title: A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients With Aortic Regurgitation
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)
- Being tested
- Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System, SAVR
- Medical subject headings
- Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV SystemDevice
Transcatheter Aortic Valve Replacement (TAVR) with Trilogy Device
SAVRDevice
SAVR using commercially available surgical prosthetic valves.
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Experimental | Transcatheter Aortic Valve Replacement (TAVR) using the Trilogy THV System Receives: Device: Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System |
| SAVR | Other | SAVR using commercially available surgical prosthetic valve Receives: Device: SAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality
all-cause mortality at 12 months
Measured: 12 months
All stroke
Number of patients that had stroke
Measured: 12 months
unplanned cardiac rehospitalization
Number of patients who had unplanned cardiac rehospitalization
Measured: 12 months
Secondary outcomes (20)
Length of index hospitalization
comparing TAVR length of index hospitalization with SAVR
Measured: pre-intervention/procedure surgery
Echocardiographic effective orifice area
comparing TAVR Echocardiographic effective orifice area with SAVR
Measured: 30 days
Moderate or greater patient prosthesis mismatch as measured by echo
comparing TAVR moderate or greater patient prosthesis mismatched with SAVR
Measured: 30 days or immediately after the intervention/procedure
Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS)
comparing change in KCCQ-OS in TAVR with SAVR. the minimum and maximum values vary based on the questionnaire. Higher scores mean better outcome.
Measured: 30 days
Atrial fibrillation
comparing the onset atrial fibrillation in TAVR with SAVR
Measured: 30 days
Cardiovascular rehospitalization
comparing the number of cardiovascular rehospitalizations in TAVR with SAVR
Measured: 30 days
Composite primary endpoints
comparing the superiority of the composite primary endpoint and its components in TAVR with SAVR
Measured: 30 days
Composite primary endpoints
comparing the superiority of the composite primary endpoint and its components in TAVR with SAVR
Measured: 1 year
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
Measured: 30 days
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
Measured: 6 months
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
Measured: 1 year
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
Measured: 2 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
Measured: 3 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
Measured: 4 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
Measured: 5 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
Measured: 6 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
Measured: 7 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
Measured: 8 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
Measured: 9 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start18 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionFeb 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,016 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JenaValve Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vinod H Thourani, MD, Principal investigator, Piedmont Heart InstituteTorsten P Vahl, MD, Principal investigator, Columbia UniversityRaj Makkar, MD, Principal investigator, Cedars-Sinai Medical CenterHendrik Treede, MD, Principal investigator, Department of Cardiovascular Surgery Johannes-Gutenberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608823
- Sponsor's protocol ID
- JVT24001
- Acronym
- ARTIST
- Status last verified
- Jun 2026
- First submitted
- 17 Sep 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No