Table 1.

Summary of CardioMEMS clinical studies

Study	Methodology	Patient population	Sample size	Endpoint	HF hospitalization	Relative risk reduction (RRR)
CHAMPION	Prospective, randomized, double‐blinded	NYHA III HFpEF or HFrEF	550 280—control 270—treatment	HFH 6 months	0.44—control 0.32—treatment	28% [0.60–0.85], P = 0.0002 37% (annualized) [0.52–0.77], P < 0.0001
CMS post‐approval	Retrospective cohort	FFS Medicare HFrEF/HFpEF	1114	HFH 6 months	1020 events—pre 381 events—post	55% [0.49–0.61], P < 0.001
CardioMEMS post‐approval	Prospective, open‐label, single‐arm	NYHA Class III & prior HFH within 12 months	1200	HFH 12 months	1.25—pre 0.54—post	57% [0.39–0.47], P < 0.0001
MEMS‐HF	Prospective, open‐label, single‐arm	NYHA Class III, ≥1 HFH in the preceding year	234	HFH 12 months	1.55—pre 0.60—post	62% [0.31–0.48], P < 0.0001
GUIDE‐HF	Prospective, randomized, double‐blinded	NYHA Class II–IV, ≥1 HFH or elevated BNP in the preceding year	3600	HFH, IV diuretics visits and all‐cause mortality 12 months	In process	In process

CI, confidence interval, CMS, Center for Medicare and Medicaid Services; FFS, fee for service, GUIDE‐HF; Hemodynamic‐GUIDEd Management of Heart Failure; HFH, heart failure hospitalization; HFpEF, heart failure preserved ejection fraction; HFrEF, heart failure reduced ejection fraction; NYHA, New York Heart Association