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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Trans-septal (TS) Mitral Valve Replacement (TSMVR) Valve system
Device
Trans-catheter, trans-septal mitral valve replacement.

Treatment groups

240 Participants

are divided into 1 treatment group

Group A: Single-arm studyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

All-cause mortality or heart failure (HF) hospitalization

The rate of all-cause mortality or heart failure (HF) hospitalization at 24 months post-implant.

Time frame

24 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HighLife SAS

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: