ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Part of paid clinical trials in Burlingame, California.
- Sponsor
- JenaValve Technology, Inc.
- Study ID
- NCT06608823
- Status
- Recruiting
Conditions
- Aortic Insufficiency
- Aortic Regurgitation
- Aortic Valve Insufficiency
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System — DEVICETranscatheter Aortic Valve Replacement (TAVR) with Trilogy Device
- SAVR — DEVICESAVR using commercially available surgical prosthetic valves.
Study Details
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)
Key Dates
- Start date
- Jun 18, 2025
- Status verified
- Apr 2026
- Primary completion
- Jun 30, 2026
- Completion
- Feb 29, 2036
Study Design
- Enrollment
- 1,016 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Transcatheter Aortic Valve Replacement (TAVR)Transcatheter Aortic Valve Replacement (TAVR) using the Trilogy THV System
- Other: SAVRSAVR using commercially available surgical prosthetic valve
Primary Outcome Measure
All-Cause Mortality [ Time Frame: 12 months ]
Central Contacts
- Duane Pinto, MD MPH949-767-2110
Locations (27)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| CPMC Sutter Health | Burlingame | California | 94010 | David Daniels, MD (PRINCIPAL_INVESTIGATOR) |
| Scripps Health | La Jolla | California | 92037 | Curtiss Stinis, MD (PRINCIPAL_INVESTIGATOR) |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Raj Makkar, MD (PRINCIPAL_INVESTIGATOR) |
| Los Robles Medical Center | Thousand Oaks | California | 91360 | Saibal Kar, MD (PRINCIPAL_INVESTIGATOR) |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | Ron Waksman, MD (PRINCIPAL_INVESTIGATOR) |
| BayCare Health | Clearwater | Florida | 33756 | Joshua Rovin, MD (PRINCIPAL_INVESTIGATOR) |
| HCA North Florida | Gainesville | Florida | 32605 | Charles Klodell, MD (PRINCIPAL_INVESTIGATOR) |
| Emory University Hospital | Atlanta | Georgia | 30308 | Adam Greenbaum, MD (PRINCIPAL_INVESTIGATOR) |
| Piedmont Healthcare | Atlanta | Georgia | 30369 | Pradeep Yadav, MD (PRINCIPAL_INVESTIGATOR) |
| Heart Care Centers of IL / Hinsdale Hospital | Chicago | Illinois | 60521 | Ravi Ramana, DO (PRINCIPAL_INVESTIGATOR) |
| Ascension St. Vincent Heart Center | Carmel | Indiana | 46290 | Cari Fekete Ezequiel Munoz, MD (PRINCIPAL_INVESTIGATOR) |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02420 | Marie-France Poulin, MD (PRINCIPAL_INVESTIGATOR) |
| University of Michigan | Ann Arbor | Michigan | 48109 | Allison Schley Stanley Chetcuti, MD (PRINCIPAL_INVESTIGATOR) |
| Henry Ford Health | Detroit | Michigan | 48202 | Tiberio Frisoli (PRINCIPAL_INVESTIGATOR) |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | Mario Goessl, MD (PRINCIPAL_INVESTIGATOR) |
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | Mark Russo, MD (PRINCIPAL_INVESTIGATOR) |
| Buffalo General Medical Center | Buffalo | New York | 14203 | Vijay Iyer, MD (PRINCIPAL_INVESTIGATOR) |
| Columbia University Medical Center | New York | New York | 10032 | Torsten Vahl, MD (PRINCIPAL_INVESTIGATOR) |
| The Christ Hospital | Cincinnati | Ohio | 45219 | Amanda Sears Santiago Garcia, MD (PRINCIPAL_INVESTIGATOR) |
| Ohio Health | Columbus | Ohio | 43214 | Carlos Sanchez, MD (PRINCIPAL_INVESTIGATOR) |
| Oregon Health & Science University (OHSU) | Portland | Oregon | 97239 | Harsh Golwala, MD (PRINCIPAL_INVESTIGATOR) |
| Lankenau Institute for Medical Research | Philadelphia | Pennsylvania | 19096 | Basel Ramlawi, MD (PRINCIPAL_INVESTIGATOR) |
| Houston Methodist Research Institute | Houston | Texas | 77030 | Melissa Alanis, RN Marvin Atkins, MD (PRINCIPAL_INVESTIGATOR) |
| Baylor Scott & White Health | Plano | Texas | 75074 | Srini Potluri, MD (PRINCIPAL_INVESTIGATOR) |
| Intermountain Health | Murray | Utah | 84107 | Brian Whisenant, MD (PRINCIPAL_INVESTIGATOR) |
| Sentara Norfolk | Norfolk | Virginia | 23507 | Matthew Summers, MD (PRINCIPAL_INVESTIGATOR) |
| University of Washington | Seattle | Washington | 98195 | Scott DeRoo, MD (PRINCIPAL_INVESTIGATOR) Christine Chung, MD (PRINCIPAL_INVESTIGATOR) |
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