Actively Recruiting
JenaValve Trilogy for Patients With Pure Native Aortic Valve Regurgitation: the ARTEMIS Data Collection Study
Led by IRCCS Policlinico S. Donato · Updated on 2025-12-24
75
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to observe the safety and effectiveness of the JenaValve Trilogy174 Heart Valve System for treating patients with severe native aortic regurgitation who are recommended for transcatheter aortic valve replacement (TAVR). The study collects data in a real-world clinical setting and includes patients considered high risk for traditional surgical valve replacement. This investigator-initiated study will monitor outcomes to better understand the device's performance in this specific patient group. The JenaValve Trilogy174 Heart Valve System includes a prosthetic transcatheter porcine pericardial aortic valve and related delivery tools such as an introducer sheath and catheter designed for transfemoral access. Patients with symptomatic severe aortic regurgitation treated with this device, either retrospectively or prospectively, will be included. The study follows patients for 1 year after enrollment, with a possible extension to 5 years, after which patients continue with standard care. Participants will be monitored through regular follow-up visits for up to one year to assess device success and safety. The primary outcome measure is device success at 12 months. After the study period, patients return to usual care under their healthcare providers. This observational study collects important information on the real-world use of the JenaValve Trilogy System in managing severe aortic regurgitation.
CONDITIONS
Brief Title
The ARTEMIS Data Collection Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Considered at high or prohibitive risk for surgical aortic valve replacement by the Heart Team
- 18 years of age or older
- Suitable anatomy according to the Instructions for Use (IFU)
- No significant disease of the ascending aorta, including no ascending aortic aneurysm (diameter less than 50mm) or severe atheroma
You will not qualify if you...
- Known hypersensitivity or contraindication to Nitinol (titanium and/or nickel)
- Contraindication to anti-coagulation or anti-platelet therapy that cannot be managed with premedication
- Allergy or contraindication to contrast medium that cannot be managed with premedication
- Active bacterial endocarditis or other active infections
- Anatomy not suitable for the JenaValve Trilogy Heart Valve System as per inclusion criteria
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.
1 visit (in-person)
Duration - Single procedure
Participants undergo transcatheter aortic valve replacement (TAVR) using the JenaValve Trilogy Heart Valve System to treat severe native aortic regurgitation.
1 procedure visit (in-person)
Duration - Up to 1 year
Participants are followed for safety and effectiveness outcomes after the valve replacement procedure in a real-world clinical setting.
Approximately 4 to 5 follow-up visits (in-person)
Trial Site Locations
Total: 1 location
1
IRCCS Policlinico San Donato
San Donato Milanese, Milano, Italy, 20097
Actively Recruiting
Research Team
F
Federica Rossi, Study Coordinator
M
Mattia Ricotti, CET specialist
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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