The ARTEMIS Data Collection Study

IRCCS Policlinico S. Donato75 enrolled

Overview

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

Conditions

Aortic Regurgitation Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milano, Italy

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 12 months

Central Contacts

Federica Rossi, Study Coordinator

CONTACT

0252774984 federica.rossi@grupposandonato.it

Mattia Ricotti, CET specialist

CONTACT

0252774236 mattia.ricotti@grupposandonato.it

Data from ClinicalTrials.gov

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