Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

Launched by ABBOTT MEDICAL DEVICES · Feb 8, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a new treatment called the Tendyne Transcatheter Mitral Valve System for patients who have significant mitral regurgitation, a condition where the heart's mitral valve doesn’t close properly, causing blood to flow backward. The trial is especially focused on patients who have had severe mitral annular calcification, a hardening of the valve area that makes traditional surgery difficult. Participants will either receive the Tendyne device or a different device called the MitraClip, and the study aims to compare how well these two options work for relieving symptoms and improving heart function.

To be eligible for this trial, patients should have symptoms from moderate to severe mitral regurgitation or severe mitral annular calcification. They must also be determined by their heart care team to have already received appropriate treatment for their condition. Throughout the study, participants will attend several follow-up visits over five years to monitor their health and the effectiveness of the treatment. This trial is currently recruiting patients aged 65 and older, and it's important for interested individuals to discuss with their doctors whether they meet the study's criteria and if they might benefit from participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Symptomatic, moderate-to-severe or severe mitral regurgitation, or severe mitral annular calcification (MAC)
• • NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)
• • The local site heart team determines that the subject has been adequately treated per applicable standards
• • Not a member of a vulnerable population
• Exclusion Criteria:
• • Mitral valvular vegetation or mass
• • Left ventricular ejection fraction \< 25%
• • Left ventricular end diastolic diameter \> 7.0 cm
• • Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material
• • Aortic valve disease requiring surgery or transcatheter intervention
• • Severe tricuspid regurgitation or any tricuspid valve disease requiring surgery or transcatheter intervention
• • Any planned surgical / interventional procedure within 60 day prior to or following subject randomization
• • Subject undergoing hemodialysis due to chronic renal failure
• • Mitral pathoanatomy and left ventricular outflow tract anatomy deemed not suitable for Trial device implantation
• • Subjects with non-cardiac comorbidities that are likely to result in a life expectancy of less than 12 months