Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
VisCardia Inc.
Study ID
NCT06552637
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Synchronized Diaphragmatic Stimulation — DEVICE
    Implantable Pulse Generator system providing cardiac-gaited stimulation of the diaphragm and thereby influence cardiovascular properties relevant in heart failure.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Jul 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Device and Medical Management
    * Subjects will be implanted with the VisONE System programmed to deliver SDS (Therapy On) and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines) including those drugs to be determined by the subject's physician * Assigned Interventions: * Device: VisONE System (SDS) * Drug: Medical Management
  • Sham Comparator: Medical Management
    * Subjects will be implanted with the VisONE System programmed not to deliver SDS (Therapy Off) and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines) including those drugs to be determined by the subject's physician * Assigned Interventions: * Drug: Medical Management

Primary Outcome Measure

Left ventricular End-Systolic Volume (LVESV) [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Aditya Parikh, MD
[email protected]
(215) 615-4949
Aditya Parikh, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
University of Pennsylvania· Philadelphia, PA

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