Health TrialsbyHealthPanel

Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure

ConditionHeart Failure With Reduced Ejection Fraction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVisCardia Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT)

QRS duration ≤ 130 ms

EF≤ 40%

Disqualifiers

Baseline 6 minute walk test > 500 meters or < 200 meters

NT-proBNP< 250 if on loop diuretics, or NT-proBNP < 500 if not on loop diuretics

Supine resting heart rate > 140 bpm

Systolic blood pressure < 80 mmHg or > 170 mmHg

Trial design

Design model

Parallel

Treatments tested in this trial

  • Synchronized Diaphragmatic Stimulation

    Device

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

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: Device and Medical ManagementExperimental treatment 1 intervention
Group B: Medical ManagementSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Left ventricular End-Systolic Volume (LVESV)

To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger percent improvement in LVESV at 6 months post-randomization from baseline than medical management alone.

Time frame
6 months
2

Six Minute Hall Walk (6MHW)

To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in 6MHW at 6 months post-randomization from baseline than medical management alone.

Time frame
6 months
3

Minnesota Living with Heart Failure quality of Life Score (MLWHF QOL)

To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in MLWHF QOL at 6 months post-randomization from baseline than medical management alone.

Time frame
6 months
4

Major Adverse Respiratory and Cardiovascular Events (MARCE)

To demonstrate the safety of the VisONE System by analyzing Major Adverse Respiratory and Cardiovascular Events (MARCE) occurring within 6 months post implant for the rate, severity and association with the device or procedure (goal \>70% freedom): * Cardiovascular Death * Stroke * Cardiac Arrest * Interaction with cardiac rhythm device requiring permanent termination of SDS therapy * Acute Heart Failure Decompensation * Infection requiring device/lead explant * Diaphragmatic dysfunction leading to a clinically significant reduction is respiratory function * Inadequate SDS therapy delivery requiring surgical intervention * Injury to abdominal organs requiring surgical intervention * Pneumothorax * Hemothorax

Time frame
6 months

Secondary outcomes

1

Left Ventricular Ejection Fraction (LVEF)

To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in LVEF at 6 months post-randomization from baseline than medical management alone.

Time frame
6 months
2

N-Terminal Pro Brain Natriuretic Peptide (NT-proBNP)

To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger reduction in NT-proBNP (log-10 transformed) at 6 months post-randomization from baseline than medical management alone.

Time frame
6 months
3

Left ventricular End-Systolic Volume (LVESV)

To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger percent improvement in LVESV at 12 months post-randomization from baseline than medical management alone.

Time frame
12 months
4

Six Minute Hall Walk (6MHW)

To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in 6MHW at 12 months post-randomization from baseline than medical management alone.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VisCardia Inc.

Lead sponsor

Clinical Accelerator

Collaborator

Duke Clinical Research Institute

Collaborator

Source ClinicalTrials.gov
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