Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

3 września 2026 zaktualizowane przez: 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)

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

30

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Urządzenie: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Freedom from device- or procedure-related major adverse events (MAEs) through 30 days post procedure
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Freedom from primary endpoint MAEs
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 3 hours after start of therapy
Urinary sodium concentration measured in a spot urine sample
3 hours after start of therapy
Weight loss
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

FlowMod, Inc.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

5 września 2026

Zakończenie podstawowe (Szacowany)

15 lutego 2027

Ukończenie studiów (Szacowany)

15 maja 2027

Daty rejestracji na studia

Pierwszy przesłany

24 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 września 2026

Pierwszy wysłany (Rzeczywisty)

9 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • CP1207

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj