Table 5.

Upcoming studies in transcatheter mitral valve replacement (TMVR) technologies.

Device	Study Name	Study Design	Inclusion Criteria	Primary Outcome
Tendyne	Clinical trial to evaluate the safety and effectiveness of using the Tendyne mitral valve system for the treatment of symptomatic mitral regurgitation (MR) (SUMMIT) NCT03433274	Prospective multicentre study with three cohorts: (a) Randomized cohort: 1:1 basis with MitraClip (b) Non-randomized cohort © MAC cohort Number of participants: 958	Symptomatic, moderate-severe, or severe MR, or severe mitral annular calcification (MAC)	(a) Randomized cohort: Survival free of HF hospitalization at 12 months (b) Non-randomized cohort: composite of all-cause mortality, CV related rehospitalization, stroke, or MV reintervention or reoperati©(c) MAC cohort: survival free of HF rehospitalization at 12 months
Intrepid	Transcatheter mitral valve replacement with the medtronic Intrepid™ TMVR system in patients with severe symptomatic MR (APOLLO) NCT03242642	Multicentre, single arm, non-randomized study with two cohorts (a) Primary cohort: moderate-severe or severe MR not suitable for TEER or surgical MVR (b) MAC cohort: moderate-severe or severe-MR with MAC	Moderate-severe or severe MR High surgical risk Not suitable for TEER	(a) Primary cohort: all-cause mortality or heart failure hospitalization at 30 days or KCCQ improvement < 10 composite (b) MAC cohort: composite of all-cause mortality and heart failure hospitalization
EVOQUE	Edwards EVOQUE EOS mitral valve replacement: investigation of safety and performance after mitral valve replacement with a transcatheter device (MISCEND) NCT02718001	Multicentre, prospective, single arm non-randomized study examining the safety and performance of the EVOQUE device in MR Number of participants: 83	Symptomatic mitral regurgitation High surgical risk Meeting anatomical criteria for the EVOQUE device	Major adverse events within 30 days
HighLife	Feasibility study of the HighLife 28mm trans-septal trans-catheter mitral valve in patients with moderate-severe or severe mitral regurgitation and at high surgical risk NCT04029363	Multicentre, single arm non-randomized study evaluating the feasibility, safety, and performance of the HighLife 28 mm TMVR Number of participants: 50	Moderate-severe or severe MR High risk for surgery Meeting anatomical criteria for the HighLife valve	Major adverse events within 30 days
HighLife Clarity	HighLife TSMVR feasibility study of the open cell CLARITY valve in patients with moderate-severe or severe MR, high surgical risk, and with a high risk for left ventricular outflow tract obstruction (LVOTO) NCT04888247	Open label, single centre, single arm, non-randomized study to assess the feasibility, safety, and performance of the HighLife CLARITY transeptal mitral valve replacement system Number of participants: 15	Moderate-severe or severe MR High surgical risk Meets anatomical criteria for HighLife Clarity valve High risk of LVOTO	Technical success: (a) Successful vascular access delivery and retrieval (b) Deployment and correct positi©ng (c) Freedom from additional emergency surgery or re-intervention related to the device or access
Sapien M3	Sapien M3 system transcatheter mitral valve replacement via transseptal access. The ENCIRCLE trial NCT04153292	Open label, single arm non-randomized study with two cohorts (a) Patients deemed unsuitable for surgical MVR (b) Patients with failed attempt at TEER Number of participants: 400	Moderate-severe or severe MR Unsuitable for surgical MVR due to clinical anatomical or technical considerations Failed attempt at TEER	Death and/or HF rehospitalization
CardioValve	CardioValve transfemoral mitral valve system (AHEAD) (United States) NCT03813524	Open label, multicentre, single arm, non-randomized study (United States centres) Number of participants: 15	Symptomatic severe MR High surgical risk LVEF ≥ 30% Cardiac index > 2.0 Patients must be receiving GDMT for at least 30 days prior to enrollment	Technical success (a) Successful access, delivery, and retrieval of the device (b) Successful deployment and correct pos©oning (c) Freedom from emergency surgery or reintervention related to the device Without procedure death, stroke, or device dysfunction
	European feasibility study of the CardioValve transfemoral mitral valve system (AHEAD study)	Open label, multicentre, single arm, non-randomized study (European centres) Number of participants: 30	Symptomatic severe MR High surgical risk Anatomy suitable for the CardioValve device Patients must be receiving GDMT for at least 30 days prior to enrolment (or CRT if indicated)	Freedom from all-cause mortality and major adverse events
AltaValve	AltaValve early feasibility study protocol	Open label, multicentre, single arm, non-randomized study Number of participants: 15	Severe symptomatic MR High surgical risk	Major adverse cardiac events at 30 days (death, stroke, and MV related repeat intervention)