The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement
ConditionMitral Regurgitation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHighLife SAS
About this trial
Post-market registry for post-market surveillance, as part of the post-market plan, for the HighLife transcatheter, transseptal, mitral valve replacement system in a real world commercial setting.
Eligibility criteria
Qualifiers
Participant is indicated for the HighLife TSMVR system per the current approved Instructions For Use (IFU)
Participant (≥ 18 years age) with severe or moderately severe mitral valve regurgitation (MR) due to primary (i.e. degenerative) and/or secondary (i.e. functional MR.
Left Ventricular Ejection Fraction (LVEF) ≥ 30%
Left ventricular end-diastolic dimension (LVEDD) ≤ 70 mm
Disqualifiers
Significantly calcified mitral valves;
Severe mitral annular calcification
Narrow femoral arteries that don't allow the passage of 18F sheaths;
More than 80 cm between the aortic valve and the femoral access;
Trial design
Treatments tested in this trial
- Not listed
Trial groups
150 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov