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Gesynchroniseerde diafragmatische stimulatie bij symptomatisch hartfalen (RECOVER-HF)

19 oktober 2026 bijgewerkt door: VisCardia Inc.

RECOVER-HF - Gerandomiseerd, multicenter, dubbelblind onderzoek naar gesynchroniseerde diafragmatische stimulatie (SDS) voor verbetering van symptomatisch hartfalen met verminderde ejectiefractie

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Symptomatic Diaphragmatic Stimulation (SDS) is a novel extra-cardiac device for patients who have symptomatic heart failure. Elevated intracardiac pressures are the hallmark of heart failure (HF) and a key pathological driver of disease progression and limited exertional capacity. The degree of cardiac pressure elevation is determined by preload, afterload, and pericardial restraint. The pericardium restrains the heart, and the degree of restraint is determined by the pericardial structure itself and the intrathoracic pressure. This aspect of HF pathophysiology is among the fundamental drivers behind the SDS therapy concept. SDS induces a temporal modulation of intrathoracic pressure.. When synchronized with the cardiac cycle, SDS may improve cardiac filling, cardiovascular pressure conditions, and cardiac performance

RECOVER HF is a prospective, randomized, doubled-blinded study of Synchronized Diaphragmatic Stimulation (SDS) delivered in an imperceptible manner in subjects with heart failure defined as New York Heart Association (NYHA) functional class II/III, left-ventricular ejection fraction (LVEF) <=40%, and QRS duration <=130ms despite receiving the appropriate heart failure guideline directed medical therapy (GDMT). All subjects will receive an implanted VisONE System. Two-weeks post implant subjects will be randomized in a 1:1 ratio into a SDS therapy active or control (SDS therapy inactive) arm with both arms receiving GDMT. At 6 months the control arm will have SDS therapy activated with all patients receiving therapy and GDMT throughout the remainder of the study period. The study will be conducted at up to 30 investigational sites in the United States and several outside the U.S. These centers will enroll subjects with the goal of randomizing approximately 270 subjects who meet the entry criteria.

Studietype

Ingrijpend

Inschrijving (Geschat)

270

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Georgië
      • Tbilisi, Georgië, 0159
        • Werving
        • Tbilisi Heart and Vascular Clinic
        • Hoofdonderzoeker:
          • Tamaz Shaburishvili, MD
        • Contact:
          • Tamaz Shaburishvili, MD
          • Telefoonnummer: 0322 157 159
  • Verenigde Staten
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46260
        • Werving
        • Ascension St. Vincent Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Sangita Sudharshan, MD
    • Oklahoma
      • Tulsa, Oklahoma, Verenigde Staten, 74136
        • Werving
        • Saint Francis Hospital
        • Hoofdonderzoeker:
          • Ralph D Ensley, MD
        • Contact:
          • Ralph D Ensley, MD
          • Telefoonnummer: (918) 494-8500
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • Werving
        • University of Pennsylvania
        • Hoofdonderzoeker:
          • Aditya Parikh, MD
        • Contact:
          • Aditya Parikh, MD
          • Telefoonnummer: (215) 615-4949
    • Texas
      • Houston, Texas, Verenigde Staten, 77030
        • Werving
        • Baylor College of Medicine
        • Hoofdonderzoeker:
          • Ajith Nair, MD
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT) for 3 months
  • EF≤ 40%
  • At the time of consent, willing and able to comply with protocol requirements, including attending all required visits
  • Willing to participate in the study and able to sign an informed consent form
  • ≥18 years of age at the time of consent

Exclusion Criteria:

  • 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, AF (episodes > 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:

    1. Greater than mild mitral valve stenosis
    2. Greater than moderate mitral valve regurgitation
    3. Greater than mild tricuspid valve stenosis
    4. Greater than moderate-severe tricuspid valve regurgitation
    5. Greater than moderate aortic stenosis
    6. Greater than moderate aortic regurgitation
    7. Greater than mild-moderate pulmonic stenosis
    8. Greater than moderate pulmonic regurgitation

  • Severe primary pulmonary disease, including pulmonary arterial hypertension. PAP sys >70 mmHg at rest

  • Severe COPD, other respiratory or lung diseases where FEV1 < 50%

  • Presence of more than small pleural effusion or history of pleural drainage within the previous 6 months

  • Known history of diaphragmatic paralysis or suspicion confirmed by unilateral or bilateral elevation of the diaphragm on chest x-ray

  • Pericardial disease

  • Non-cardiac condition substantially impairing ambulation of 6-minute hall walk test interpretation

  • Existing diaphragmatic stimulation for respiration assist

  • Present LVAD, Baroreflex Activation Therapy, Cardiac Contractility Modulation or interatrial shunt devices; temporary mechanical cardiac assist devices (current or within the previous 3 months)

  • Contraindications to laparoscopic access to the diaphragm, as determined by the implanting physician

  • Known intra-abdominal pathology which could increase the risk of laparoscopic access to the diaphragm.

  • Previous open laparotomy within 1 year

  • Previous thoracic or abdominal organ transplant

  • Drug induced immuno-suppression

  • Body mass index > 40

  • Enrollment in a concurrent investigation / clinical study

  • Having a life expectancy of <1 year due to any condition

  • Pregnant or planning a pregnancy during the study period

  • Known allergies to implantable device materials

  • History of systemic infection requiring the use of intravenous antibiotics within the previous 3 months

  • Received cardiac resynchronization therapy (CRT) within six months of randomization, or is actively receiving CRT

  • Currently have a Class I indication for a cardiac resynchronization therapy (CRT) device according to AHA/ACC/ESC guidelines for the treatment of congestive heart failure

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Apparaat: Synchronized Diaphragmatic Stimulation

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

Andere namen:
  • SDS
  • Asymptomatische diafragmatische stimulatie
  • ADVERTENTIES
  • VisONE veiligheidsinformatieblad
Sham-vergelijker: 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
Apparaat: Synchronized Diaphragmatic Stimulation

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

Andere namen:
  • SDS
  • Asymptomatische diafragmatische stimulatie
  • ADVERTENTIES
  • VisONE veiligheidsinformatieblad

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Left ventricular End-Systolic Volume (LVESV)
Tijdsspanne: 6 months

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)
Tijdsspanne: 6 months

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)
Tijdsspanne: 6 months

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)
Tijdsspanne: 6 months

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Left Ventricular Ejection Fraction (LVEF)
Tijdsspanne: 6 months

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.
6 months
N-Terminal Pro Brain Natriuretic Peptide (NT-proBNP)
Tijdsspanne: 6 months

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.
6 months
Left ventricular End-Systolic Volume (LVESV)
Tijdsspanne: 12 months

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.
12 months
Six Minute Hall Walk (6MHW)
Tijdsspanne: 12 months

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.
12 months
Minnesota Living with Heart Failure quality of Life Score (MLWHF QOL)
Tijdsspanne: 12 months

To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in MLWHF QOL at 12 months post-randomization from baseline than medical management alone.
12 months
Left Ventricular Ejection Fraction (LVEF)
Tijdsspanne: 12 months

To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in LVEF at 12 months post-randomization from baseline than medical management alone.
12 months
N-Terminal Pro Brain Natriuretic Peptide (NT-proBNP)
Tijdsspanne: 12 months

To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger reduction in NT-proBNP (log-10 transformed) at 12 months post-randomization from baseline than medical management alone.
12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

VisCardia Inc.

Medewerkers

Duke Clinical Research Institute
Clinical Accelerator

Onderzoekers

  • Hoofdonderzoeker: Lee R Goldberg, MD, University of Pennsylvania

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 juli 2026

Primaire voltooiing (Geschat)

1 juli 2028

Studie voltooiing (Geschat)

1 december 2029

Studieregistratiedata

Eerst ingediend

6 augustus 2024

Eerst ingediend dat voldeed aan de QC-criteria

9 augustus 2024

Eerst geplaatst (Werkelijk)

14 augustus 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

19 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • VisCardia H03_22

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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