Atrial Shunt Device for Heart Failure
Trial Summary
What is the purpose of this trial?
Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on stable heart failure treatment according to guidelines, which suggests you may continue your current medications if they are part of this treatment.
What data supports the effectiveness of the treatment Corvia Atrial Shunt System / IASD System II for heart failure?
Is the Atrial Shunt Device safe for humans?
How is the Corvia Atrial Shunt System different from other heart failure treatments?
The Corvia Atrial Shunt System is unique because it is a device implanted through a catheter that creates a small opening between the heart's upper chambers, helping to reduce pressure in the left atrium and improve symptoms in heart failure patients with preserved ejection fraction. This approach is different from traditional heart failure treatments, which often involve medications or lifestyle changes.12345
Research Team
Martin Leon, MD
Principal Investigator
Columbia University
Sanjiv Shah, MD
Principal Investigator
Northwestern Memorial Hospital
Eligibility Criteria
The RESPONDER-HF Trial is for adults over 40 with chronic heart failure who are experiencing symptoms despite current treatment. They must have a history of hospitalization or elevated NT-pro BNP levels, be in NYHA class II-IV, and have stable heart function and management. Participants need to agree to follow-up visits and provide consent. Exclusions include recent cardiac events, other significant health issues, women who can become pregnant, severe mental health conditions, participation in conflicting studies, certain implanted devices or structural heart repairs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either the Corvia Atrial Shunt implant procedure or a sham procedure with echocardiography
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of heart failure events and other cardiovascular outcomes
Unblinding
All patients will be unblinded after the 24-month follow-up visit
Treatment Details
Interventions
- Corvia Atrial Shunt System / IASD System II
Find a Clinic Near You
Who Is Running the Clinical Trial?
Corvia Medical
Lead Sponsor