RESPONDER-HF is a prospective, global, double-blinded, randomized trial with the potential to change the way heart failure is treated. The purpose of this study is to confirm the clinical efficacy of the Corvia Atrial Shunt in HF patients with LVEF ≥40%, elevated left sided filling pressures, and who remain symptomatic despite optimal Guideline Directed Medical Therapy (GDMT).
Randomized, double-blinded, sham-controlled, prospective study
Approximately 60 sites in the United States, Europe, Australia & Canada
Enrolling Q4 ‘22
260 randomized 1:1
HFpEF & HFmrEF (EF≥40%)
Primary Composite Endpoint
Rate of total HF events (first and recurrent) up to 24 months, analyzed when last randomized patient reaches 12 months. KCCQ change from baseline to 12 months.
Major Secondary Endpoint
Rate of cardiovascular death through 12 months
Visit www.clinicaltrials.gov (NCT05425459) for additional trial information.
RESPONDER-HF is the latest in a series of clinical studies evaluating the Corvia Atrial Shunt. It builds on learnings from previous studies and is designed to confirm the Responder Group results of the landmark REDUCE LAP-HF II trial and thereby inform which heart failure patients may benefit most from atrial shunting.
If you are interested in trial participation or would like more information about the RESPONDER-HF study, please contact us at RESPONDER-HF@corviamedical.com.
If you have a patient that may be a good candidate for RESPONDER-HF, please reach out directly to the clinical trial site to determine patient eligibility. A list of participating centers may be found at www.clinicaltrials.gov (NCT05425459)