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The ARTEMIS Data Collection Study

NCT ID: NCT07075861

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-10

Study Completion Date

2028-08-10

Brief Summary

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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

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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.

Conditions

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Aortic Regurgitation Disease

Keywords

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JenaValve Trilogy Aortic Regurgitation TAVI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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patients with symptomatic, severe, native aortic regurgitation

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Policlinico S. Donato

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luca Testa, PI

Role: PRINCIPAL_INVESTIGATOR

IRCCS Policlinico San Donato (San Donato Milanese) - IT

Locations

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IRCCS Policlinico San Donato

San Donato Milanese, Milano, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Federica Rossi, Study Coordinator

Role: CONTACT

Phone: 0252774984

Email: [email protected]

Mattia Ricotti, CET specialist

Role: CONTACT

Phone: 0252774236

Email: [email protected]

Facility Contacts

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Federica Rossi, Study Coordinator

Role: primary

Mattia Ricotti

Role: backup

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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CET 203-2025

Identifier Type: -

Identifier Source: org_study_id