Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Launched by MEDTRONIC CARDIOVASCULAR · Aug 9, 2022

Keywords

ClinConnect Summary

The APOLLO-EU Trial is studying a new heart procedure called transcatheter mitral valve replacement (TMVR) using the Medtronic Intrepid™ system. This trial focuses on patients with severe mitral regurgitation, a condition where the heart's mitral valve does not close properly, causing blood to flow backward. The main goal is to find out if this procedure is safe and effective for people who have significant symptoms but are not suitable for standard surgical options or other repair methods.

To participate in the trial, patients must be between 65 and 74 years old and have been diagnosed with moderate-to-severe mitral regurgitation or a combination of mitral regurgitation and stenosis (narrowing of the valve). They also need to be evaluated by a specialized heart team that determines they cannot undergo traditional treatments. If eligible, participants will undergo the new procedure and will need to attend follow-up visits to monitor their progress. It's important to note that this trial is currently recruiting participants, and those interested should discuss their options with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject has moderate-to-severe or severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines and Standards - Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation, or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of MAC
• • Local site multidisciplinary heart team experienced in mitral valve therapies agrees that patient is unsuitable for treatment with approved transcatheter repair or conventional mitral valve surgery
• • Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
• • Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
• • Subjects anatomically suitable for the Medtronic Intrepid™ TMVR TF System
• Exclusion Criteria:
• • Estimated life expectancy of less than 24 months
• • Currently surgically implanted mitral valve
• • Prior transcatheter mitral valve procedure with device currently implanted
• • Anatomic contraindications
• • Anatomically prohibitive mitral annular calcification (MAC)
• • Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment
• • LVEF \< 25% (measured by resting transthoracic echocardiogram), patients with LVEF 25 - \<30% will be further evaluated by the Screening Committee for approval (Right Ventricular Dysfunction, pulmonary hypertension, and left ventricular function)
• • Left ventricular end diastolic diameter (LVEDD) \> 75mm
• • Need for emergent or urgent surgery
• • Hemodynamic instability
• • History of bleeding diathesis or coagulopathy
• • End stage renal disease
• • Liver failure
• • Frailty