HighLife Clarity Treatment of Severe Mitral Regurgitation
ConditionMitral Valve (MV) Regurgitation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHighLife SAS
About this trial
The purpose of the study is to evaluate the safety and effectiveness of the HighLife transcatheter trans-septal mitral valve replacement (TSMVR) system in NYHA Class ≥ II-IV patients with moderate-to-severe or severe mitral regurgitation (MR) who, by assessment of the local Heart Team, are unsuitable for treatment with approved transcatheter repair (sub-optimal results to complex or prohibitive edge-to-edge repair) or surgical mitral valve intervention according to guidelines.
Eligibility criteria
Qualifiers
Based on local regulations, the subject meets the legal minimum age to provide informed consent
Moderate-to-severe or severe symptomatic MR (≥3+) by transthoracic echocardiography (TTE) which is primarily due to lack of mitral leaflet coaptation, secondary to either a) LV cardiomyopathy with restriction of the mitral leaflet(s), or b) mitral annular dilatation due to chronic atrial fibrillation or other cause, as confirmed by the echocardiographic core laboratory (note: some element of primary (degenerative) MR may be present, but the core lab must agree that the principal etiology is secondary MR)
New York Heart Association (NYHA) functional class II, III or ambulatory IV
being treated with stable maximally-tolerated doses of guidelines class I indicated GDMT for at least one month, and CRT for at least 3 months (if applicable)
Disqualifiers
Any stroke or TIA within 30 days prior to procedure; any prior intracranial hemorrhage at any time; or any intracerebral mass, arteriovenous fistula or other malformation or defect predisposing to bleeding
Known severe carotid stenosis (>70% diameter stenosis by non-invasive imaging) or carotid stenting or carotid endarterectomy within 30 days)
History of bleeding diathesis, coagulopathy, clotting disorder, or refusal of future blood transfusion or bleeding in the 3 months prior to procedure other than minor cutaneous bleeding
Patients in whom transesophageal echo (TEE) is not feasible
Trial design
Treatments tested in this trial
- Trans-septal (TS) Mitral Valve Replacement (TSMVR) Valve system
Treatment groups
240 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov