Coapt

Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients

Coapt [NCT01626079]

Description: The purpose of the Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in high surgical risk subjects.

Device: MitraClip System; Device: Standard of Care only / No Device

Primary Investigator: Sarembock

Drug/Device Information
MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in high surgical risk subjects.
Percutaneous therapy delivered via transseptal catheterization
Randomized 1:1 (MitraClip Device vs. no device)
Abbott Vascular