ARTEMIS: JenaValve Trilogy data collection for severe aortic regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ARTEMIS is a single-arm, retrospective/prospective post-market data collection that follows up to 75 patients treated with the JenaValve Trilogy system for severe native aortic regurgitation. The study captures real-world safety and effectiveness outcomes after TAVR using the Trilogy valve, with planned follow-up to one year (an extension to five years may be added). Enrollment is at IRCCS Policlinico San Donato and includes patients selected by the local heart team who meet the device instructions for use. Data collected will include procedural details, complications, and clinical outcomes reported under routine clinical care.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCCS Policlinico San Donato
  San Donato Milanese, Milano, Italy Recruiting

Study contacts

• Principal investigator: Luca Testa, PI — IRCCS Policlinico San Donato (San Donato Milanese) - IT
• Study coordinator: Federica Rossi, Study Coordinator
• Email: federica.rossi@grupposandonato.it
• Phone: 0252774984

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.