Acute Decompensated Heart Failure Heart failure
Conditions
Interventions
The TRVD* System is to be used during a renal venous catheterization procedure.
In brief, a single procedure is performed by inserting the RVD* Steerable
Introducer into the femoral vein and advanci
once fully in
place, the pump head expands. The pressure at the tip of the catheter reflects
the renal venous pressure (RVP) and the TRVD* Console will operate the
propeller at the speed that is ne
Sponsors
Magenta Medical Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient is 18 years of age or older 2. Patient admitted to the hospital with a primary diagnosis of ADHF who is chronically treated with at least one oral loop diuretic. 3. Patient presents at least two of the following clinical signs of manifest volume overload: 3.1 Jugular venous distension 3.2 Dyspnea, rales, or evidence of pulmonary congestion or oedema on admission chest radiography 3.3 Abdominal discomfort compatible with internal organ congestion and/or hepatomegaly 3.4 Peripheral oedema 4. Ultrasonic evidence of IVC plethora, defined as IVC diameter >2.0 cm. 5. BNP levels >300 pg/dL or NT-proBNP >1500 pg/dL . 6. Evidence of cardiac etiology as per cardiac ultrasonography. 7. LVEF /
Exclusion criteria
Exclusion criteria: Clinical and general criteria: ;1. INR >3, use of a NOAC in the past 48 hours or contraindication to systemic anticoagulation with Heparin. 2. Evidence of hemodynamic instability, evidence of shock with organ hypoperfusion, or need for inotropic support. 3. Overt pulmonary oedema, or Respiratory insufficiency/hypoxia (peripheral haemoglobin saturation 35). 14. Fluid retention that is not primarily of cardiac origin (e.g., advanced liver disease, severe hypo-albuminaemia, etc.) 15. Temperature > 38°C (oral or equivalent), or sepsis, or active systemic infection requiring IV anti-microbial treatment. 16. Large ascites per ultrasound/CT. 17. Cognitive impairment. 18. Planned PCI, or more than minor surgery in the next 3 months. 19. Moribund patient, or patient with malignancy or other comorbidities limiting life expectancy to less than one year. 20. Patient has a known allergy to Nickel. 21. Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication. 22. Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints. ;CT Imaging: ;Patient has renal venous anatomy that is unsuitable for device placement for treatment, including: 23. Renal vein length /= 16 mm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Safety - Serious Adverse Events (SAE): device related SAEs rate through 30 days post index procedure (Refer to definition in Appendix B). Safety data will be collected throughout study period. - Feasibility - Technical Success: Successful delivery and deployment of the RVD* Catheter via the RVD* Introducer, on an intention-to-treat basis, adequate function during device operation and successful retrieval of the RVD* Catheter and RVD* Introducer. Procedural Success: Technical Success and the absence of device-related SAE through hospital discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| - RVP reduction from baseline during therapy: assessed in hospital - CVP reduction from baseline: assessed in hospital - Total net fluid loss from baseline: assessed in hospital (post urine catheter placement till removal). - In-hospital daily change in body weight. - Change in parameters of sodium excretion (sodium/potassium ration, total and fractional excretion of sodium) from baseline to 24, 48, 72 and 96 hours and discharge. - Change in IVC dimensions and collapsibility index per ultrasound from baseline to 24, 48 and 96 hours and discharge. - Ultrasonic evidence of decongestion (as per IVC size) at 24, 48 and 96 hours and discharge. - Change in neuroendocrine profile (plasma renin and aldosterone levels) throughout hospitalization and at 30-day follow up (not obligatory per protocol). - In-hospital daily change and follow-up change in Patient Global Assessment (PGA) and dyspnea using the Visual Analogue Scale (VAS) compared to baseline. - Change in the cardiac biomarker (NT-proBNP or BNP) from baseline to 24, 48, 72 and 96 hours and discharge. - Change in renal biomarkers (urinary NGAL and KIM-1 and serum Cystatin C) from baseline to 48, 72 and 96 hours and discharge (not obligatory per protocol). - Plasma free haemoglobin at baseline, 6, 12, 24, 48, 72, 96 hours and hospital discharge. - Change in body weight at follow-up compared to baseline. - Clinical decongestion at 48 and 96 hours, as well as hospital discharge, 30 days and 90 days following discharge. Clinical congestion will be graded based on edema, rales, jugular venous pressure, and weight. *- Change in creatinine from baseline to discharge and at the 90-day follow-up visit; peak creatinine during hospitalization. *- In-hospital daily change in serum electrolytes (sodium, potassium and chloride) *- In-hospital daily change in IV diuretic dose. *- Diuretic response defined as urinary Sodium content/loop diuretic dose as well as total urinary volume/loop diuretic dose | — |
Countries
Netherlands
Outcome results
None listed