The ARTEMIS Data Collection Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Aortic Regurgitation Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
JenaValve Trilogy for Patients With Pure Native Aortic Valve Rigurgitation: the ARTEMIS Data Collection Study
Overview
To observe the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with evere native aortic regurgitation (AR) who are indicated for TAVR Data collection
Detailed description
To observe the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with evere native aortic regurgitation (AR) who are indicated for TAVR Data collection .
A retrospective/prospective, single-arm, post-market study to monitor the outcomes of Jena Valve Trilogy in a real-world clinical setting .
After enrollment is completed, patients are followed to 1 year (an amendment to extend the follow up to 5 years will be evaluated). Thereafter, the patient exits the data collection study and is to be followed per institutional standard of care for TAVR patients.
The JenaValve Trilogy™ Heart Valve System contains the following sub-components: a prosthetic transcatheter porcine pericardial aortic valve, 20Fr Introducer Sheath System, transfemoral Delivery Catheter, and Loading Tool.
Indications for Use: The JenaValve Trilogy™ Heart Valve System is indicated for use in patients with clinically significant aortic regurgitation (AR) who are considered high risk candidates for surgical aortic valve replacement as deemed by the local multi-disciplinary heart team.
This is an investigator initiated study that will include 75 suitable patients according to the inclusion/exclusion criteria as per IFU.
Primary outcome measures
- Device success at 12 months [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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 IFU
- Absence of significant disease of the ascending aorta, including ascending aortic aneurysm (defined as maximal luminal diameter of 50mm or greater) or atheroma (especially if thick \[>5mm\], protruding or ulcerated)
Exclusion criteria
The JenaValve Trilogy Heart Valve System is contraindicated for use in patients who have known hypersensitivity or contraindication to Nitinol (titanium and/or nickel), an anti-coagulation/anti-platelet regimen or contrast medium that cannot be managed with premedication, or who have active bacterial endocarditis or other active infections.
The JenaValve Trilogy Heart Valve System is contraindicated in those patients whose anatomy does not accommodate the System due to anatomical considerations outlined in the inclusion criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Policlinico San Donato — San Donato Milanese
Identifiers
NCT: NCT07075861 · CET 203-2025