No phaseRecruiting

Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure (RECOVER-HF)

RECOVER-HF - RandomizEd, Multi-Center, Double-Blinded Study of SynchrOnized Diaphragmatic Stimulation (SDS) for ImproVEment of Symptomatic Reduced Ejection Fraction Heart Failure

Sponsor
VisCardia Inc. (Industry)
Enrolment
270 planned
Conditions
Heart Failure With Reduced Ejection Fraction
Interventions
Synchronized Diaphragmatic Stimulation
Ages
adults, older adults
Registry
NCT06552637

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Left ventricular End-Systolic Volume (LVESV)
  • Six Minute Hall Walk (6MHW)
  • Minnesota Living with Heart Failure quality of Life Score (MLWHF QOL)
  • Major Adverse Respiratory and Cardiovascular Events (MARCE)

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered