The ARTEMIS Data Collection Study

NCT07075861 | Recruiting

• 1 other identifier: CET 203-2025
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Aortic Regurgitation Disease

Keywords

JenaValve Trilogy; Aortic Regurgitation; TAVI

Outcome Measures

Primary Outcomes (1)

• Device success at 12 months

  Freedom from all-cause mortality * Freedom from unsuccessful delivery of the device, and retrieval of the delivery system * Freedom from incorrect positioning of a single prosthetic heart valve into the proper anatomical location * Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication * Intended performance of the valve (i.e., no moderate or severe prosthetic valve regurgitation)

  12 months

Study Arms (1)

patients with symptomatic, severe, native aortic regurgitation

patients with symptomatic, severe, native aortic regurgitation retrospectively or prospectively treated with TAVI JenaValve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with severe symptomatic aortic valve regurgitation in a native valve. According to the local experience in TAVR, the number of patients with severe AR deemed at prohibitive surgical risk is around 2/month. Considering a prospective enrollment of 2 years and historical patients collected data for 1 year, the final number of expected patients will be about 75. In fact, according to reference \[1\], a composite of all-cause mortality and heart failure ehospitalization at 1 year had cumulative incidence of about 17%. Therefore, considering an exponential distribution with event rate 0.17 (17 events per 100 person years), 75 patients amount to a total of 75-13\*.5=68 person years. The resulting 95% confidence interval of the cumulative incidence will be 0.06; 0.24 \[2\].

You may qualify if:

• Considered at high or prohibitive risk for surgical aortic valve replacement by the Heart Team
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milano, 20097, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Luca Testa, PI

  IRCCS Policlinico San Donato (San Donato Milanese) - IT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federica Rossi, Study Coordinator

CONTACT

0252774984; federica.rossi@grupposandonato.it

Mattia Ricotti, CET specialist

CONTACT

0252774236; mattia.ricotti@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): August 10, 2028
• Study Completion (Estimated): August 10, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)