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NCT06608823 · ClinicalTrials.gov registry record · NA
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
A NA study of Aortic Valve Insufficiency and Aortic Regurgitation, sponsored by JenaValve Technology.
- Recruiting
- Registry status
- NA
- Development phase
- 1,016
- Enrollment target
- 20
- Study locations
NCT06608823: Recruiting NA study of Aortic Valve Insufficiency and Aortic Regurgitation, sponsored by JenaValve Technology.
NCT06608823 is a NA study of Aortic Valve Insufficiency and Aortic Regurgitation that is actively recruiting participants, run by JenaValve Technology. The registered enrollment target is 1,016 participants, below the 1,299-participant average among 11 other Aortic Valve Insufficiency trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06608823, a NA study of Aortic Valve Insufficiency and Aortic Regurgitation, is actively recruiting participants, sponsored by JenaValve Technology.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,016 participants
- Enrollment target
- 20
- Study locations
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)
Primary Outcome
all-cause mortality at 12 months
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 |
What NCT06608823 shows while recruiting
NCT06608823 is an interventional study that assigns participants to a tested intervention. Its 1,016 participants enrollment target places it among the larger protocols in the corpus, below the 1,299-participant average among 11 other Aortic Valve Insufficiency trials with a reported enrollment target (22% lower).
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.
NCT06608823 names 20 study sites across 12 states, led by California, Florida, Georgia.
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.
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).
Who is sponsoring clinical trial NCT06608823?
This trial is sponsored by JenaValve Technology, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06608823's enrollment target sits among peer trials
1,016 3rd of 11 higher than 9 of 11 other Aortic Valve Insufficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Valve Insufficiency trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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