NCT05425459

RESPONDER-HF Trial

Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved Ejection Fraction (EF) Heart Failure (Protocol #2201)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Corvia Medical · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization

Detailed description

Following supine bicycle exercise hemodynamic assessment to verify eligibility, patients are sedated then randomized to the treatment or control group. Patients in both arms will undergo placement of femoral venous access sheath. Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and Corvia Atrial Shunt implant procedure. Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium. Patients will be evaluated at pre-specified time intervals and followed for 5 years. All patients will be unblinded after the 24 month follow up visit.

Conditions

• Heart Failure
• Heart Failure, Diastolic

Interventions

Type	Name	Description
DEVICE	Corvia Atrial Shunt System / IASD System II	The primary component of the system is an implant placed in the atrial septum designed to allow left to right flow between the left atrium and right atrium to reduce the elevated left atrial pressure.
OTHER	Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)	Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) for examination of the atrial septum and left atrium.

Timeline

• Start date: 2022-11-17
• Primary completion: 2027-07-01
• Completion: 2031-03-01
• First posted: 2022-06-21
• Last updated: 2026-03-18

Locations

61 sites across 7 countries: United States, Australia, Austria, Belgium, Canada, Germany, Netherlands

Regulatory

• FDA-regulated device study