REDUCE LAP-HF II Trial
LANDMARK TRIAL in HFpEF
REDUCE LAP-HF II is the largest device therapy trial for heart failure patients with preserved ejection fraction (HFpEF), the biggest unmet need in cardiology. This global, landmark, phase III, sham-controlled trial is evaluating the Corvia Atrial Shunt in heart failure patients to reduce HF-related hospitalizations and improve quality of life through a reduction in left atrial pressure (LAP), the primary cause of HF symptoms. Patients will be followed out to 5 years post implant.
The 12-month primary endpoint analyses reinforce the safety and efficacy of the device observed in previous studies and have newly defined treatable patient population for atrial shunt therapy.
Responder Group Highlights
50% of the study population benefited significantly from atrial shunt therapy despite an overall neutral trial2,3
Neutral primary outcome when including all patients (win ratio=1)
RESPONDER GROUP (n=313)
Positive outcome in patients with normal exercise PVR (<1.74 WU)4 and no cardiac rhythm device (win ratio5=1.5, p=0.004)
Read the REDUCE LAP-HF II Responder publication in Circulation
Download REDUCE LAP HF-II Clinical Summary
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- Berry N, Mauri L, Feldman T,. et al. Transcatheter InterAtrial Shunt Device for the treatment of heart failure: Rationale and design of the pivotal randomized trial to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure II (REDUCE LAP-HF II). Am Heart J, 2020; 226:222-31.
- Shah SJ, Borlaug BA, Chung ES, et al. Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II): a randomised, multicentre, blinded, sham-controlled trial. Lancet. 2022;399(10330):1130-1140.
- Borlaug, BA, Blair, J, Bergmann, MW et al. Latent Pulmonary Vascular Disease May Alter the Response to Therapeutic Atrial Shunt Device in Heart Failure. Circulation. 2022;10.1161. (in press)
- Upper tertile, which roughly corresponds to peak exercise in a healthy adult >55 years (≤1.8WU).
- In win ratio calculation, all patients are compared with each other in pairwise manner on values of the components in a hierarchical manner (1 = neutral, >1 treatment better, <1 sham better).