Clinical Evidence
Results from the RELIEVE-HF clinical study1
Significant Benefit for HFrEF Patients
In RELIEVE-HF, HFrEF (LVEF ≤40%) patients who received a shunt had 48% fewer heart failure hospitalizations (HFH) over 24 months compared to control. This drove a 45% reduction in combined heart failure events* for HFrEF shunt treatment patients over the same time period. The V-Wave Ventura Interatrial Shunt has an excellent safety record.2
Study Design
A prospective, randomized, double-blind, placebo procedure controlled, multicenter, pivotal trial that evaluated the safety and efficacy of the V-Wave Ventura lnteratrial Shunt for the treatment of heart failure.
Patient Baseline Characteristics
Patients Treated with Maximally Tolerated GDMT
HFrEF patients (N=206) were treated with stable, maximally tolerated, guideline-directed medical therapy (GDMT) regimens. Baseline medications and devices were reviewed by eligibility committee.
Primary Safety Endpoint
Measured as device- or procedure-related MACNE† at 30 days. Performance goal set at 11%.
Primary Efficacy Endpoint
Defined as hierarchical composite endpoint||: death, LVAD or transplant, HFH,§ worsening HF events#, KCCQ score¶
In the IIT group, the win ratio was neutral at0.86 ([95% CI, 0.61-1.22)
The HFpEF and HFrEF strata findings were directionally opposite (p=0.0275) and therefore are considered individually
Significant Benefit for HFrEF Patients
HFrEF patients with a shunt experienced a 45% reduction in combined heart failure events (death, LVAD/transplant, HFH, or worsening HF). This was driven primarily by a 48% decrease in the rate of heart failure hospitalizations.
HFpEF Patient Outcomes in RELIEVE-HF
HFpEF patients had worse outcomes with shunt compared to control and an observed 68% increase in the rate of combined heart failure events (death, LVAD/transplant, HFH, or worsening HF) in 24 months (HR, 1.68 [95% CI 1.29-2.19]).
Footnotes
*Combined heart failure events: death, LVAD/transplant, HFH, or worsening HF.
†MACNE in treatment patients is defined as all-cause death, stroke, systemic embolism, need for open cardiac surgery, or major endovascular surgical repair.
‡Technical success: measured at exit from cath lab and is defined as alive, with successful access, delivery, and retrieval of the transcatheter V-Wave delivery system, with deployment and correct positioning of the intended device and no need for additional emergency surgery or reintervention related to either the device or the access procedure.
§Heart failure hospitalization (HFH) includes emergency room heart failure visits with duration ≥6 hours
¶KCCQ–Kansas City Cardiomyopathy Questionaire#Worsening outpatient heart failure events include emergency room heart failure visits with duration <6 hours.
||Measured as a hierarchy via the Finklestein Finkelstein-Schoenfeld statistical methodology, and expressed as a WIN ratio.
References
Stone GW, Lindenfeld J, Rodes-Cabau J, et al. Interatrial shunt treatment for heart failure: the randomized RELIEVE-HF trial. Circulation. Dec 10,2024;150(24):1931-1943.doi:10.1161/CIRCULATIONAHA.124.070870
Stone G. RELIEVE-HF study design and results. Presented at: TCT Annual Conference: Pioneering Advances in Interventional Cardiology; October 17, 2025; Moscone Center, San Francisco, CA. Session: Interatrial Shunting for Patients with HFrEF: New Data, New Insights.
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