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

Launched by HIGHLIFE SAS · Jul 20, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the HighLife trans-septal Transcatheter Mitral Valve Replacement System. It aims to see if this device is safe and effective for patients with severe mitral regurgitation, which is a condition where the heart's mitral valve doesn't close properly, causing blood to leak backward into the heart. This study focuses on patients who are at high risk for traditional surgery due to other health issues.

To be eligible for the trial, participants must be at least 18 years old and have severe mitral regurgitation. They should also have been on optimal heart medication for at least three months and be considered inoperable or at high risk for surgery by a team of heart specialists. If you join the study, you will receive close monitoring and care from a dedicated medical team throughout the trial. It's important to note that certain conditions may prevent someone from participating, such as specific heart diseases or recent surgeries. Overall, this trial could offer a new treatment option for patients who might not have many choices left.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Main Exclusion Criteria:
• • 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