Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure

NCT06552637 | Recruiting DMC FDA Device

• 1 other identifier: VisCardia H03_22
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Heart Failure; Heart Disease; Synchronized Diaphragmatic Stimulation; Implantable Heart Failure Device Therapy

Outcome Measures

Primary Outcomes (4)

• 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.

  6 months

• 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.

  6 months

• 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.

  6 months

• 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

  6 months

Secondary Outcomes (7)

• Left Ventricular Ejection Fraction (LVEF)

  6 months

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

  6 months

• Left ventricular End-Systolic Volume (LVESV)

  12 months

• Six Minute Hall Walk (6MHW)

  12 months

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

  12 months

Study Arms (2)

Device and Medical Management

EXPERIMENTAL

* 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

Device: Synchronized Diaphragmatic Stimulation

Medical Management

SHAM COMPARATOR

* 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

Device: Synchronized Diaphragmatic Stimulation

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.

Also known as: Asymptomatic Diaphragmatic Stimulation, SDS, ADS, VisONE SDS

Device and Medical Management; Medical Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT)
• QRS duration ≤ 130 ms
• EF≤ 40%

You may not qualify if:

• 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
• Serum creatinine \> 2.5 mg/dL
• Serum hepatic function 3x ULN
• Any of the following within the previous 3 months: unstable angina, AMI, CABG, PTCA, CVA/TIA, persistent AF (\> 24 hours), symptomatic NSVT or DCCV
• Any inotropic drug treatment within the previous 3 months
• Bradycardia (heart rate \< 50 beats/min), atrial arrhythmias with rates \> 100 beats/min, sustained ventricular tachycardia or frequent ventricular ectopy \>10% present during screening
• Significant uncontrolled symptomatic bradyarrhythmia, atrial fibrillation, unstable ventricular arrhythmias or frequent ventricular ectopy \> 10% documented within the previous 3 months
• Reversible non-ischemic cardiomyopathy
• Valvular disease requiring intervention within the next 12 months or presence of significant valve disease as determined by the site cardiologist as:
• Greater than mild mitral valve stenosis
• Greater than moderate mitral valve regurgitation
• Greater than mild tricuspid valve stenosis

Sponsors & Collaborators

• VisCardia Inc.: lead
• Duke Clinical Research Institute: collaborator
• Clinical Accelerator: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Lee R Goldberg, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Arand, Ph.D.

CONTACT

5034313823; arandp@viscardia.com

Peter Bauer, Ph.D.

CONTACT

5034313824; bauerp@viscardia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and care provider blinded to device programming, therapy imperceptible to patient, data analysis through independent entities
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Initial randomization into Control and Therapy arms for 6 month primary endpoints, afterwards crossover of Control arm into Therapy arm for 12 month secondary endpoints.

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 14, 2024
• Study Start: April 30, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)