Navitor Japan Study
ConditionSevere Aortic Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorAbbott Medical Devices
About this trial
The Navitor Japan Study is designed to evaluate the safety and performance of the Navitor™ valve used in combination with the FlexNav™ delivery system in a contemporary, real-world setting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is eligible per the current approved indication after Heart Team discussion and intended to undergo a Navitor TAVI procedure.
The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the EC of the respective clinical site.
The patient and the treating physician agree that the subject will return for all required post-procedure follow-up visits
Disqualifiers
Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU).
Life expectancy < 12 months from the time of informed consent due to non-cardiac co-morbid conditions.
In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study.
Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated.
Trial population
Patients with symptomatic, severe aortic stenosis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Navitor Transcatheter Aortic Valve Implantation
DeviceSubjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Cohort 11 intervention
Trial outcomes
Primary outcomes
1
Primary Safety Endpoint
The primary safety endpoint is all-cause mortality at 30 days post-TAVI procedure, which will be assessed descriptively
Time frame
30 days post index procedure2
Primary Performance Endpoint
The primary performance endpoint is moderate or greater paravalvular leak (PVL) at 30 days as measured on a transthoracic echocardiogram (TTE) by the echocardiographic core laboratory. This endpoint will be reported as % subjects with moderate or greater PVL at 30 days.
Time frame
30 days post index procedureSponsors and contacts
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Source ClinicalTrials.gov