Efficacy and safety of interatrial shunt treatment for heart failure: A systematic review and meta-analysis

Table 1 Study characteristics of the included studies

Ref.	Device	Study design	Device	Left ventricular ejection fraction	New York Heart Association class	Participants control	Participants IASD	Follow-up
Søndergaard et al[17], 2014	IASD	Pilot trial	IASD	≥ 45%	III/IV	11	11	1 month
Kaye et al[4], 2016	IASD	Single-arm study	IASD	≥ 40%	II/IV	64	64	12 months
Del Trigo et al[18], 2016	V-wave	Cohort study	V-wave	≤ 40%	III/IV	10	10	3 months
Feldman et al[10], 2018	IASD	Phase 2, randomized control trial	IASD	≥ 40%	III/IV	22	21	1 months
Rodés-Cabau et al[19], 2024	V-wave	Non-randomized control trial (single-arm open-label study)	V-wave	> 15%	III/IV	38	36	12 months
Paitazoglou et al[7], 2021	AFR device	Prospective, multicentre, open-label, non-randomised pilot	AFR device	≥ 15%	III/IV	36	36	3 months
Stone et al[20], 2024	Ventura shunt	Randomized, double-blind, placebo procedure–controlled, multicenter trial	Ventura shunt	30.2% (≤ 40%) in 206 patients and preserved 55.8% (> 40%) in 302 patients	II–IVa	258	250	2 years
Gustafsson et al[21], 2024	IASD system II (Corvia Medical)	Multicenter, randomized, double blind, sham-controlled trial	IASD system II (Corvia Medical)	≥ 50%	II/III	312	309	2 years
Fioretti et al[12], 2025	APTURE shunt	Open-label, single-arm, nonrandomized trial	APTURE shunt	> 40%	II–IV	106	95	2 years

AFR: Atrial flow regulator; IASD: Interatrial shunt device.