Healthcare Professionals
RESPONDER-HF Trial
Study Overview
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).
Study Design
Randomized, double-blinded, sham-controlled, prospective study
Clinical Sites
Approximately 60 sites in the United States, Europe, Australia & Canada
Status
Enrolling Q4 ‘22
Participants
260 randomized 1:1
Population
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.
Who Should be Considered?
Patients who have symptomatic HF or unexplained exertional dyspnea may be candidates for the RESPONDER-HF study. Refer to the H2FPEF Scoring tool to help identify HFpEF among patients with exertional dyspnea.
Key inclusion criteria
- Age ≥40
- Left ventricular ejection fraction ≥40%
- New York Heart Association class II–IV
- Relatively normal right ventricular function
- Elevated left-sided filling pressures
- Absence of significant valve disease
- Absence of a cardiac rhythm management device
Participating Centers
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)