Comparative Observational Study of Supra-annular Versus Intra-annular Self-expanding Aortic Valves in Routine Clinical Practice

ConditionTrans-catheter Aortic Valve Implantation

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity Hospital, Montpellier

About this trial

We proposed to compare in an observational study procedural success at one month (VARC 3 criteria) and clinical and echographic follow-up at 6 months between 2 self expandable devices in TAVR : the supra annular Evolut device (Medtronic) vs the intra anular NAVITOR device (Abott)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

all patients elligible for TAVR witn a self expandable device

Disqualifiers

femoral access not suitable

valve in valve procedures

Trial population

patients with indication of femoral TAVR for aortic stenosis after heart team decision

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

419 Participants

are grouped into 2 trial groups

Group A: patients with indication of TAVR - supra annular design device

Group B: patients with indication of TAVR - intra annular design device

Trial outcomes

Primary outcomes

Device success according to VARC 3 criteria

Time frame

1 month follow up

Sponsors and contacts

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University Hospital, Montpellier

Lead sponsor

Source ClinicalTrials.gov

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