Healthcare Professionals

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, and 12-month follow-up is not complete.

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 study patients demonstrated a significant clinical benefit
(responder group)

45%

reduction in heart failure event rate vs. sham control

55%

greater improvement in KCCQ vs. sham control at 12 months

Exercise phenotyping identified as critical for patient selection

Reduce LAP-HF II Trial Design1

PURPOSE: Evaluate the clinical efficacy and safety of the Corvia Atrial Shunt to improve quality of life and reduce HF related symptoms and events in patients with HFpEF or HFmrEF.

Study Population

(N=626 randomized)

  • Symptomatic HF
  • Ongoing GDMT
  • Age ≥40
  • LVEF ≥40%
  • Preserved RV function
  • Elevated exercise PCWP (≥25 mm Hg) with left-to-right gradient (≥5 mm Hg)
  • Pulmonary vascular resistance (PVR) <3.5 Wood units at rest or peak exercise

Atrial Shunt Treatment

(N=314)

Sham Control

(N=312)

Trial Outcome

50% of the study population benefited significantly from atrial shunt therapy despite an overall neutral trial2,3

OVERALL POPULATION

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)

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)

OVERALL POPULATION

Neutral primary outcome when including all patients (win ratio=1)

Responder Group Outcomes (N=313)

Heart Failure Event Rate

Corvia Atrial Shunt therapy led to a 45% reduction in the rate of heart failure events

Cumulative Heart Failure Events

Heart failure event curves separated early in the trial and continued to diverge through the 2-year mark

Quality of Life

At 12 months, atrial shunt patients reported a 55% greater improvement over their baseline KCCQ score compared to sham control

Health Status

Atrial shunt therapy patients were 2x as likely to improve to NYHA Class I or II compared to sham control

Exercise Capacity

At 12 months, atrial shunt therapy patients significantly improved 6-minute walk distance

Key Safety Outcomes
Responder population at 1 yearAtrial Shunt therapy (N=161)Sham control (N=152)P-value
Cardiovascular mortality1/161 (0.6%)0/152 (0.0%)0.96
Non-fatal ischemic stroke1/161 (0.6%)0/152 (0.0%)0.96
New or worsening kidney dysfunction12/161 (7.5%)16/152 (10.5%)0.34
Major adverse cardiac events3/161 (1.9%)0/152 (0.0%)0.95
Other thrombo-embolic complications0/161 (0.0%)0/152 (0.0%)
≥30% Decrease in TAPSE3/161 (1.9%)3/152 (2.0%)0.94
Expert Roundtable

Global experts Prof. Andrew Coats, Dr. Barry Borlaug, Dr. Sanjiv Shah and Prof. Gerd Hasenfuß provide insight into the REDUCE LAP-HF II responder group findings and contextualize the study results within the broader HFpEF landscape.

Circulation Publication

Read the REDUCE LAP-HF II Responder publication in Circulation

Clinical Summary

Download REDUCE LAP HF-II Clinical Summary

Interested in learning more?

Please reach out to your local Corvia field representative or contact us.

  1. 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.
  2. 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.
  3. 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)
  4. Upper tertile, which roughly corresponds to peak exercise in a healthy adult >55 years (≤1.8WU).
  5. 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).