The ARTEMIS Data Collection Study (ARTEMIS)

JenaValve Trilogy for Patients With Pure Native Aortic Valve Rigurgitation: the ARTEMIS Data Collection Study

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

Study Overview

• Status: Recruiting
• Conditions: Aortic Regurgitation Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Federica Rossi, Study Coordinator; Phone Number: 0039 0252774984; Email: federica.rossi@grupposandonato.it
• Study Contact Backup: Name: Mattia Ricotti, CET specialist; Phone Number: 0039 0252774236; Email: mattia.ricotti@grupposandonato.it

Study Locations

• Italy
  • Milano
    • San Donato Milanese, Milano, Italy, 20097
      • Recruiting
      • IRCCS Policlinico San Donato
      • Contact: Federica Rossi, Study Coordinator; Phone Number: 0039 0252774984; Email: federica.rossi@grupposandonato.it
      • Contact: Mattia Ricotti; Phone Number: 0039 0252774236; Email: mattia.ricotti@grupposandonato.it
      • Principal Investigator: Luca Testa, PI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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].

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
patients with symptomatic, severe, native aortic regurgitation; patients with symptomatic, severe, native aortic regurgitation retrospectively or prospectively treated with TAVI JenaValve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Donato
• Investigators: Principal Investigator: Luca Testa, PI, IRCCS Policlinico San Donato (San Donato Milanese) - IT

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2025
• Primary Completion (Estimated): August 10, 2028
• Study Completion (Estimated): August 10, 2028

Study Registration Dates

• First Submitted: July 10, 2025
• First Submitted That Met QC Criteria: July 10, 2025
• First Posted (Actual): July 20, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: TAVI; Aortic Regurgitation; JenaValve Trilogy
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: CET 203-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No