APOLLO Trial: Treatment of Mitral Regurgitation

The APOLLO Trial will evaluate the safety and efficacy of the Medtronic Intrepid^TM TMVR System in patients with moderate-to-severe or severe symptomatic mitral regurgitation who are deemed unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention by the local site multidisciplinary heart team experienced in mitral valve therapies. This will be a non-randomized, multicenter clinical trial.

In order to participate you must meet the following criteria:

• Are 18 years of age or older.
• Have moderate-to-severe or severe symptomatic mitral regurgitation or have moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of mitral annular calcification (MAC, for the MAC cohort only).
• Are unsuitable for approved transcatheter repair and surgical mitral valve intervention evaluated by multidisciplinary heart team.

You will be excluded from the study if any of the following criteria apply to you:

• Have left ventricular ejection fraction <30%.
• Have had prior transcatheter mitral valve procedure with device currently implanted.
• Have anatomic contraindications for Intrepid^TM TMVR Systems.
• Have anatomically prohibitive mitral annular calcification (MAC) 
• Have severe tricuspid regurgitation.
• Have severe COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use.
• Have had recent stroke or TIA within 90 days of enrollment.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.