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
This trial does not accept healthy volunteersQualifiers
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 population
Per Instruction For Use (IFU): Adult patients suffering from symptomatic moderate-severe or severe MR who are unsuitable for surgical repair/replacement and transcatheter edge-to-edge repair, as deemed by a multi-disciplinary heart team.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Commercial patients
Trial outcomes
Primary outcomes
1
Rate of Technical Success
To measure the rate of subjects that meet the definition of Technical success defined as an alive participant at exit from procedure room, with all of the following: * Successful vascular access, delivery and retrieval of the HighLife delivery systems * Deployment and correct positioning of the HighLife 28mm bio-prosthesis * Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure
Time frame
At exit from procedure room2
Rate of Device Success
To measure the rate of subjects that meet the definition of Device safety, defined as the freedom of major adverse events at 30 days, as follows: * All-cause mortality * Myocardial infarction * Major/disabling stroke * Life-threatening bleeding (MVARC scale) * Major access and vascular complications * Stage 2 or 3 acute kidney injury (includes dialysis) * Any mitral valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention * Severe hypotension, heart failure or respiratory failure requiring intravenous vasopressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices for ≥ 48 hours, or prolonged intubation for ≥ 48 hours
Time frame
30 days3
Primary Performance Endpoint
Rate of Total Mitral Regurgitation reduction to 1+ or less assessed by transthoracic echo (TTE), and as analyzed by an independent Core Lab
Time frame
30 daysSecondary outcomes
1
Procedural Mortality
Where patient died during the procedure before exiting the procedure room
Time frame
At exit from the procedure room2
All-cause mortality
Patient death due to any cause
Time frame
30 days, 6 months, 12 months, 1, 2, and 3 year3
Reoperation
To include conversion to surgery, reintervention to surgery or non-surgical procedure
Time frame
30 days4
Disabling stroke
Meeting the criteria of disabling versus non-disabling stroke, as defined per MVARC guidelines, to include if ischemic or hemorrhagic
Time frame
30 days, 6 months, 1, 2, 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: