Evaluation of FlowMod System While Intermittently Partially Occluding Vena Cava Blood Flow in Subjects With ADHF (FLOW-HF)
An Evaluation of the FLOWMod System to Occlude Vena Cava Blood Flow in Subjects With Acute Decompensated Heart Failure
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Jean-Maurice Dussartre, MD
- Número de telefone: +33672926156
- E-mail: jm.dussartre@flow-mod.com
Locais de estudo
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Tbilisi, Geórgia, 0186
- Tbilisi Heart Center
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Tbilisi, Geórgia
- Tbilisi Heart And Vascular Clinic
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Tashkent, Uzbequistão
- Ezgu Niyat Medical Clinic
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Tashkent, Uzbequistão
- Republican Specialized Center of Cardiology
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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%
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Freedom from device- or procedure-related major adverse events (MAEs) through 30 days post procedure
Prazo: Through 30 days post procedure
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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
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Through 30 days post procedure
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Freedom from primary endpoint MAEs
Prazo: Through 90 days post procedure
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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
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Through 90 days post procedure
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Acute Technical Success
Prazo: Immediately after the procedure
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Defined as successful device deployment, ability to intermittently partially occlude the SVC/IVC and successful device removal
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Immediately after the procedure
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Time from device removal to hospital discharge
Prazo: Through index discharge, an average of 24 hours
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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.
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Through index discharge, an average of 24 hours
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Heart failure-related re-hospitalization rates at 30 and 90 days
Prazo: 30 days and 90 days
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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.
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30 days and 90 days
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Re-hospitalization rates (any cause) at 30 and 90 days
Prazo: 30 days and 90 days
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Rate of hospital admissions occurring after index discharge for any cause
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30 days and 90 days
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Urinary spot sodium (3 hours after start of therapy)
Prazo: 3 hours after start of therapy
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Urinary sodium concentration measured in a spot urine sample
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3 hours after start of therapy
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Weight loss
Prazo: From baseline through study completion, an average of 90 days
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Change in subject body weight from baseline to protocol-specified post-treatment timepoints
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From baseline through study completion, an average of 90 days
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Time to discharge readiness
Prazo: From post-procedure to index discharge, an average of 24 hours
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Time until the subject is considered clinically ready for safe discharge according to institutional criteria and treating physician assessment.
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From post-procedure to index discharge, an average of 24 hours
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Index admission hemodialysis or continued renal replacement therapy
Prazo: Periprocedural hemodialysis, an average of 24 hours
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Occurrence of hemodialysis or continued renal replacement therapy during the index hospitalization following FlowMod therapy.
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Periprocedural hemodialysis, an average of 24 hours
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Hemodialysis post discharge through 90 days post discharge
Prazo: Through 90 days after index discharge
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Occurrence of hemodialysis after index hospital discharge
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Through 90 days after index discharge
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Modified Borg Dyspnea change from baseline, at 12 hours during therapy and post device removal
Prazo: Baseline to 12 hours during therapy and post device removal
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Change in patient-reported dyspnea severity from baseline, measured using the Modified Borg Dyspnea scale at 12 hours during therapy and after device removal
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Baseline to 12 hours during therapy and post device removal
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Diuretic efficiency changes from baseline, at 12 hours during therapy and post device removal
Prazo: At 12 hours and post device removal, an average of 24 hours
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Diuretic efficiency assessed by urinary output measured in milliliters (mL)
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At 12 hours and post device removal, an average of 24 hours
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EQ5D change from baseline at discharge, 30 and 90 days
Prazo: EQ5D from Baseline at discharge, (an average of 24 hours) and at 30 days and 90 days
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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.
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EQ5D from Baseline at discharge, (an average of 24 hours) and at 30 days and 90 days
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eGFR change from baseline and at 24 hours after initiation of therapy or hospital discharge, whichever comes first
Prazo: Baseline to 24 hours after initiation of therapy or hospital discharge, whichever occurs first
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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.
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Baseline to 24 hours after initiation of therapy or hospital discharge, whichever occurs first
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Cystatin C changes from baseline and at 24 hours after initiation of therapy or hospital discharge, whichever comes first
Prazo: Baseline to 24 hours after initiation of therapy or hospital discharge, whichever occurs first
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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
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Baseline to 24 hours after initiation of therapy or hospital discharge, whichever occurs first
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Right atrial, pulmonary artery, PCWP and cardiac output changes from baseline, at 8 hours during therapy and end of therapy
Prazo: Baseline, 8 hours during therapy, and end of therapy
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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.
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Baseline, 8 hours during therapy, and end of therapy
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
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Palavras-chave
Outros números de identificação do estudo
- CP1207
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