The ARTEMIS Data Collection Study
ConditionAortic Regurgitation Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Policlinico S. Donato
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
None
Trial 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 \[2\].
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
75 Participants
are grouped into 1 trial groupGroup A: patients with symptomatic, severe, native aortic regurgitation
Trial outcomes
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)
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov