JenaValve Trilogy for Patients With Pure Native Aortic Valve Rigurgitation: the ARTEMIS Data Collection Study
Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Italy
IRCCS Policlinico San Donato
RECRUITING
San Donato Milanese
Contact Information
Primary
Federica Rossi, Study Coordinator
federica.rossi@grupposandonato.it
0252774984
Backup
Mattia Ricotti, CET specialist
mattia.ricotti@grupposandonato.it
0252774236
Time Frame
Start Date: 2025-08-10
Estimated Completion Date: 2028-08-10
Participants
Target number of participants: 75
Treatments
patients with symptomatic, severe, native aortic regurgitation
patients with symptomatic, severe, native aortic regurgitation retrospectively or prospectively treated with TAVI JenaValve
Related Therapeutic Areas
Sponsors
Leads: IRCCS Policlinico S. Donato