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Evaluation of FlowMod System While Intermittently Partially Occluding Vena Cava Blood Flow in Subjects With ADHF (FLOW-HF)

3 septembre 2026 mis à jour par: FlowMod, Inc.

An Evaluation of the FLOWMod System to Occlude Vena Cava Blood Flow in Subjects With Acute Decompensated Heart Failure

FLOW-HF will assess the impact of intermittent partial occlusion of the SVC and/or IVC, the cardiac filling pressure and the difference of effects between the two occlusion locations (SVC and IVC) using the FlowMod flow modulating device on select parameters in subjects experiencing ADHF (Acute Decompensated Heart Failure)

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

Intermittent occlusion of the superior vena cava (SVC) and/or inferior vena cava (IVC) might be associated with positive beneficial effects on cardiac filling pressures and improved patient outcomes.

Type d'étude

Interventionnel

Inscription (Estimé)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Géorgie
      • Tbilisi, Géorgie, 0186
        • Tbilisi Heart Center
      • Tbilisi, Géorgie
        • Tbilisi Heart And Vascular Clinic
  • Ouzbékistan
      • Tashkent, Ouzbékistan
        • Ezgu Niyat Medical Clinic
      • Tashkent, Ouzbékistan
        • Republican Specialized Center of Cardiology

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

Male or females between 18 and 85 years of age

NYHA Class III-IV heart failure

Stage C-D systolic heart failure

Clinically indicated for right heart catheterization

Volume overload status of the subject confirmed by the presence of at least 1 or more of the following congestion signs or symptoms assessed by physical examination or x-ray: Peripheral edema, rales, jugular venous distension, abdominal distension or evidence of congestion by chest x-ray

Subjects with RAP >10 mmHg

Subjects with PCWP >18 mmHg

Subjects with inadequate diuresis defined as total urinary output over the most recent 8 hours prior to enrollment of <1200 mL while on a stable dose of diuretics

Subjects with eGFR >30mL/min/1.732

Exclusion Criteria:

Severe valvular stenosis

Severe aortic valve regurgitation

Subjects with a contraindication to contrast dye

Active myocardial ischemia (MI) or acute coronary syndrome (ACS)

ACS or MI within 30 days prior to enrollment

Contraindication to unfractionated heparin

Unable to provide informed consent

Subjects with impaired decision-making capacity

Subjects receiving mechanical circulatory support

Subjects with history of cardiac transplant

Pregnant subjects

Right atrial/ventricular thrombus

Subjects with inadequate jugular vein access due to prior jugular vein thrombosis or indwelling chronic ports or catheters or presence of vena cava filter

Inability to tolerate right heart catheterization

Subjects who have a history of major or minor stroke or TIA ≤ 12 months or subjects with a history of stroke > 12 months who have a residual neurological deficit

Hypersensitivity or contraindication to latex

Sustained ventricular tachycardia (>10 beats) within 24 hours and/or ventricular fibrillation within 24 hours

Subjects with history of CABG ≤ 3 months

Subjects with pacemaker or defibrillator leads placed through the SVC ≤ 3 months prior to procedure

Rapid atrial fibrillation (HR>120 bpm)

Systolic blood pressure < 90 mm Hg

Inability to interrupt the anticoagulation treatment

Subjects with known coagulopathy or any blood disorders

Subjects with life expectancy of <30 days or known risk for mortality within 90 days

Prior carotid interventions (stenting or endarterectomy)

Severe carotid disease

History of DVT (<6m or requiring ongoing anticoagulants for either DVT or hypercoagulable state)

History of pulmonary embolism

SVC/IVC stenosis

SVC/IVC diameter not suitable for balloon inflations

Subjects receiving hemodialysis or planning to within 30 days

Planned LVAD device placement

Subject on >2 inotropes or escalating inotropes during pre-enrollment hospitalization

Right ventricular failure based on an RA:PCWP ratio of >0.8, PAPi<1.0; or TAPSE<10

Subjects with Ejection Fraction (EF) of <15%

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: FlowMod System in subjects with acute decompensated heart failure (ADHF)
Participant with acute decompensated heart failure (ADHF) while the FlowMod System reduces preloading of the heart.
Dispositif: FlowMod System in subjects with acute decompensated heart failure (ADHF)
The FlowMod System is used in subjects with acute decompensated heart failure (ADHF) for limiting blood flow in the inferior and superior vena cava vessels to the right heart to reduce preloading of the heart.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Freedom from device- or procedure-related major adverse events (MAEs) through 30 days post procedure
Délai: Through 30 days post procedure
Freedom from device- or procedure-related major adverse events (MAEs) through 30 days post procedure defined as: death, myocardial infarction, major thromboembolic event, vascular damage requiring surgical intervention, hemorrhagic stroke, or prolongation of heart failure-related hospitalization, attributable to the FlowMod device or procedure
Through 30 days post procedure

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Freedom from primary endpoint MAEs
Délai: Through 90 days post procedure
Defined as: death, myocardial infarction, major thromboembolic event, vascular damage requiring surgical intervention, hemorrhagic stroke, or prolongation of heart failure-related hospitalization, attributable to the FlowMod device or procedure
Through 90 days post procedure
Acute Technical Success
Délai: Immediately after the procedure
Defined as successful device deployment, ability to intermittently partially occlude the SVC/IVC and successful device removal
Immediately after the procedure
Time from device removal to hospital discharge
Délai: Through index discharge, an average of 24 hours
Time from device removal to hospital discharge will be defined as the elapsed time, in hours, between the documented date and time of complete FlowMod device removal and the documented date and time of discharge from the index hospitalization.
Through index discharge, an average of 24 hours
Heart failure-related re-hospitalization rates at 30 and 90 days
Délai: 30 days and 90 days
defined as any hospital admission occurring after index discharge that is primarily due to worsening signs and/or symptoms of heart failure requiring inpatient treatment.
30 days and 90 days
Re-hospitalization rates (any cause) at 30 and 90 days
Délai: 30 days and 90 days
Rate of hospital admissions occurring after index discharge for any cause
30 days and 90 days
Urinary spot sodium (3 hours after start of therapy)
Délai: 3 hours after start of therapy
Urinary sodium concentration measured in a spot urine sample
3 hours after start of therapy
Weight loss
Délai: From baseline through study completion, an average of 90 days
Change in subject body weight from baseline to protocol-specified post-treatment timepoints
From baseline through study completion, an average of 90 days
Time to discharge readiness
Délai: From post-procedure to index discharge, an average of 24 hours
Time until the subject is considered clinically ready for safe discharge according to institutional criteria and treating physician assessment.
From post-procedure to index discharge, an average of 24 hours
Index admission hemodialysis or continued renal replacement therapy
Délai: Periprocedural hemodialysis, an average of 24 hours
Occurrence of hemodialysis or continued renal replacement therapy during the index hospitalization following FlowMod therapy.
Periprocedural hemodialysis, an average of 24 hours
Hemodialysis post discharge through 90 days post discharge
Délai: Through 90 days after index discharge
Occurrence of hemodialysis after index hospital discharge
Through 90 days after index discharge
Modified Borg Dyspnea change from baseline, at 12 hours during therapy and post device removal
Délai: Baseline to 12 hours during therapy and post device removal
Change in patient-reported dyspnea severity from baseline, measured using the Modified Borg Dyspnea scale at 12 hours during therapy and after device removal
Baseline to 12 hours during therapy and post device removal
Diuretic efficiency changes from baseline, at 12 hours during therapy and post device removal
Délai: At 12 hours and post device removal, an average of 24 hours
Diuretic efficiency assessed by urinary output measured in milliliters (mL)
At 12 hours and post device removal, an average of 24 hours
EQ5D change from baseline at discharge, 30 and 90 days
Délai: EQ5D from Baseline at discharge, (an average of 24 hours) and at 30 days and 90 days
Change from baseline in EQ-5D score, a standardized measure of health-related quality of life across mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with self-rated overall health status, assessed at hospital discharge, 30 days, and 90 days.
EQ5D from Baseline at discharge, (an average of 24 hours) and at 30 days and 90 days
eGFR change from baseline and at 24 hours after initiation of therapy or hospital discharge, whichever comes first
Délai: Baseline to 24 hours after initiation of therapy or hospital discharge, whichever occurs first
Change from baseline in estimated glomerular filtration rate (eGFR), calculated based on serum creatinine and used to evaluate renal function, assessed at 24 hours after initiation of FlowMod therapy or at hospital discharge, whichever occurs first.
Baseline to 24 hours after initiation of therapy or hospital discharge, whichever occurs first
Cystatin C changes from baseline and at 24 hours after initiation of therapy or hospital discharge, whichever comes first
Délai: Baseline to 24 hours after initiation of therapy or hospital discharge, whichever occurs first
Change from baseline in Cystatin C, a blood biomarker used to assess kidney function and evaluate changes over time, assessed at 24 hours after initiation of FlowMod therapy or at hospital discharge, whichever occurs first
Baseline to 24 hours after initiation of therapy or hospital discharge, whichever occurs first
Right atrial, pulmonary artery, PCWP and cardiac output changes from baseline, at 8 hours during therapy and end of therapy
Délai: Baseline, 8 hours during therapy, and end of therapy
Change from baseline in invasive hemodynamic parameters, including right atrial pressure, pulmonary artery pressure, pulmonary capillary wedge pressure, and cardiac output, assessed at 8 hours during FlowMod therapy and at end of therapy.
Baseline, 8 hours during therapy, and end of therapy

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

FlowMod, Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

5 septembre 2026

Achèvement primaire (Estimé)

15 février 2027

Achèvement de l'étude (Estimé)

15 mai 2027

Dates d'inscription aux études

Première soumission

24 août 2026

Première soumission répondant aux critères de contrôle qualité

3 septembre 2026

Première publication (Réel)

9 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • CP1207

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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