At 12 months, 73 subjects were determined to be AHI responders, per the Sher criteria*, resulting in an ITT AHI responder rate of 63.5% (p=0.002), and 82 subjects were determined to be ODI responders, ...
The RESHAPE-HF2 trial aimed to settle the debate initiated by the conflicting COAPT and MITRA-FR trials, however, it did not clarify the role of transcatheter edge-to-edge repair in heart failure.