Post-Market Clinical Follow Up Study With Navitor Valve
ConditionAortic Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorAbbott Medical Devices
About this trial
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
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 IRB (Investigational Review Board)/EC (Ethics Committee) 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
This study will enroll subjects of all genders from the population of patients qualifying for TAVI.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
DeviceSubjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System1 intervention
Trial outcomes
Primary outcomes
1
All-cause mortality at 30 days post-TAVI procedure
Death from all causes at 30 days post-TAVI procedure
Time frame
30 days post index procedure2
Moderate or greater paravalvular leak at 30 days post-TAVI procedure
Assessment of paravalvular leak at 30 days post-TAVI procedure
Time frame
30 days post index procedureSponsors and contacts
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Source ClinicalTrials.gov