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RESPONDER-HF Trial

NCT05425459 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2026-03-18

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Corvia Medical

    lead INDUSTRY

Principal Investigators

  • Sanjiv Shah, MD · Northwestern Memorial Hospital

  • Martin Leon, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-17
Primary Completion
2027-07-31
Completion
2031-03-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05425459 on ClinicalTrials.gov