An observational study in Aortic Regurgitation Disease, sponsored by IRCCS Policlinico S. Donato. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by IRCCS Policlinico S. Donato · Observational
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
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.
162 studies on the registry are indexed under Aortic Valve Insufficiency; 52 are open to participants now.
This study's planned enrollment of 75 is below the median of 216 across 70 observational studies indexed under Aortic Valve Insufficiency.
Browse Aortic Valve Insufficiency studies →IRCCS Policlinico S. Donato is the lead sponsor of 101 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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].
Considered at high or prohibitive risk for surgical aortic valve replacement by the Heart Team
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.
patients with symptomatic, severe, native aortic regurgitation retrospectively or prospectively treated with TAVI JenaValve
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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IRCCS Policlinico S. Donato