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HighLife Transcatheter Mitral Valve Replacement for Mitral Regurgitation

This study is testing a new device called the HighLife Transcatheter Mitral Valve Replacement (TMVR) System. This system is designed to replace a leaky mitral valve without open-heart surgery. It's for people with severe mitral regurgitation (a condition where the heart's mitral valve doesn't close properly, causing blood to flow backward) who are too sick for traditional surgery. The study will look at the safety of the device and how well it works after 30 days. You might be able to join if you are at least 18 years old, have severe mitral regurgitation, and your doctors believe surgery is too risky for you. The study aims to enroll 30 participants.

Study design
This is an early feasibility study, meaning it's one of the first times this device is being tested in people. It is an interventional study, and 30 participants are planned.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 30 days after the procedure to check for major adverse events and how well the device is working.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04029337

An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Recruiting
NAAges 18+InterventionalTreatment
HighLife SAS
~30 participants
Updated 2025-03-17 on ClinicalTrials.gov
What's tested:Transcatheter Mitral Valve Replacement

At a glance

Recruiting sites
8 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Freedom of major adverse events
Measured over at 30 days post procedure
+1 more outcome measured

Conditions

Mitral Regurgitation

Explore related trials

Mitral Valve Insufficiency

Where it's being run

10 sites across 10 states
Arizona1
California1
Georgia1
Massachusetts1
Minnesota1
New York1
Pennsylvania1
South Carolina1

Who to contact

Thomas Waggoner, MD
Thomas Waggoner <[email protected]>
+1 520-838-3540
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years
Severe mitral regurgitation
New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months
Multidisciplinary Heart Team consensus that the patient is inoperable or at high-risk for surgical repair/replacement due to significant co-morbid conditions
Multidisciplinary Heart Team consensus that the patient is not a suitable candidate for other approved percutaneous repair therapy due to anatomical or medical conditions
Patient meets the anatomical criteria for HighLife valve sizing as determined by CT and TEE

Exclusion

Mitral stenosis
Rheumatic valve disease
Severe calcifications of the mitral annulus and/or mitral leaflets
Prior surgical or interventional treatment of the mitral valve
Unsuitable anatomy for the transapical access
Unsuitable anatomy of the aorta and ilio-femoral vessels for the transfemoral access
Untreated clinically significant coronary artery disease requiring revascularization
LVEF \< 30%
LVEDD \> 70mm
Echocardiographic evidence of intracardiac mass, thrombus or vegetation
Hypertrophic Obstructive Cardiomyopathy (HOCM)
Any surgical or interventional procedure (including PCI) done in the past 30 days prior to procedure

What this trial measures

  • Freedom of major adverse eventsat 30 days post procedure

    including: * All-cause mortality * Myocardial infarction or coronary ischemia requiring PCI or CABG * Major stroke * Life-threatening bleeding (MVARC scale) * Major access and vascular complications * Stage 2 or 3 acute kidney injury (includes dialysis) * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention * Severe hypotension, heart failure or respiratory failure requiring intravenous pressors 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, or prolonged intubation for ≥ 48H

  • Continued intended performance of the HighLife™ bioprosthesisat 30 days post procedure

    defined as the reduction of mitral regurgitation (MR) to either optimal (0+ to trace) or acceptable (reduced by at least 1 grade from baseline with no more than 2+ MR) without significant mitral stenosis (post-procedure EOA ≥ 1.5 cm2 with a transmitral gradient \< 5mmHg) and with no greater than mild (1+) paravalvular MR (and without associated hemolysis)