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Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure

NCT06552637 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2026-03-31

No results posted yet for this study

Summary

RECOVER HF is a clinical study designed to evaluate the safety and efficacy of Synchronized Diaphragmatic Stimulation delivered using the VisONE System in the treatment of patients with heart failure.

Conditions

  • Heart Failure With Reduced Ejection Fraction

Interventions

DEVICE

Synchronized Diaphragmatic Stimulation

Implantable Pulse Generator system providing cardiac-gaited stimulation of the diaphragm and thereby influence cardiovascular properties relevant in heart failure.

Sponsors & Collaborators

  • Clinical Accelerator

    collaborator INDUSTRY

  • Duke Clinical Research Institute

    collaborator OTHER

  • VisCardia Inc.

    lead INDUSTRY

Principal Investigators

  • Lee R Goldberg, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-07-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06552637 on ClinicalTrials.gov