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ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
NCT06608823 · View on ClinicalTrials.gov ↗
Study 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)
Conditions Studied
Interventions
- DEVICE SAVR
- DEVICE Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System
Study Locations (20)
California
- CPMC Sutter Health — Burlingame
- Scripps Health — La Jolla
- Cedar-Sinai Medical Center — Los Angeles
Florida
- BayCare Health — Clearwater
- HCA North Florida — Gainesville
Georgia
- Emory University Hospital — Atlanta
- Piedmont Healthcare — Atlanta
Michigan
- University of Michigan — Ann Arbor
- Henry Ford Health — Detroit
Ohio
- The Christ Hospital — Cincinnati
- Ohio Health — Columbus
Texas
- Houston Methodist Research Institute — Houston
- Baylor Scott & White Health — Plano
Utah
- Intermountain Health — Murray
- Intermountain Healthcare — Murray
Massachusetts
- Beth Israel Deaconess Medical Center — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,016 participants |
| Start Date | 2025-06-18 |
| Est. Completion | 2036-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06608823
The ClinicalTrials.gov registry entry for NCT06608823 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,016 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is JenaValve Technology, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Aortic Valve Insufficiency appearing as the primary indexed condition, and to 2 interventions — of which SAVR is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06608823 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06608823 about?
NCT06608823 is a clinical study titled "ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™". 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)
What is the current status of trial NCT06608823?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,016 participants. The study started on 2025-06-18. Estimated completion is 2036-02.
What conditions does trial NCT06608823 study?
This clinical trial studies the following conditions: Aortic Valve Insufficiency, Aortic Regurgitation, Aortic Insufficiency. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06608823?
The interventions under investigation include: SAVR (DEVICE), Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06608823?
This trial is sponsored by JenaValve Technology, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06608823 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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