congestive heart failure with insufficient response to diuretic
Conditions
Interventions
The Doraya is a percutaneously delivered catheter which is deployed
over-the-wire using fluoroscopy and positioned in the inferior vena cava, below
both renal veins (deployment is similar to IVC fil
Sponsors
Revamp Medical Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Subject is >18 and 80 mg furosemide per day or an equivalent, or; b) >1.5X of the subject chronic baseline diuretic level With at least of one of the following: a) reduction of 12 mmHg confirmed at the beginning or prior to the catheterization procedure.
Exclusion criteria
Exclusion criteria: 1) Systolic blood pressure 38°C, ongoing uncontrolled known infection (i.e. inflammatory parameters not decreasing despite * 48 hrs of antibiotic treatment) 16) Severe obesity (BMI >35). 17) Subject with known hypersensitivity to Nickel. 18) Subject with history of radiation therapy to lower abdomen. 19) Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication. 20) Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems or requiring inotropic therapy for survival. 21) Concomitant disease expected to cause death in * 90 days 22) Any other medical, social, or psychological issues that in the opinion of the investigator preclude the subject from receiving this treatment, or the procedures and evaluations pre- and post-.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Primary Safety: Device or procedure related Serious Adverse Event (SAE) rate through 30 days post index procedure as adjudicated by a Clinical Events Committee (CEC). - Primary Feasibility: Technical success, defined as ability to position the device below the renal veins, to regulate the flow in the IVC using the device by creating a gradient pressure of at least 2 mmHg, and to withdraw the device. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Observational Measures: Clinical and observational measures (baseline, during treatment, 24 hours following treatment and at discharge): * Congestion signs & symptoms: Dyspnea (Likert scale), orthopnoea, pulmonary rales, jugular venous distension and peripheral edema. * Renal function: Urea, creatinine, eGFR, hourly urine output, daily fluid balance, daily diuretic dose. * Circulatory system hemodynamics (during treatment only): Renal Venous Pressure (RVP, continuously measured through the catheter), Right Atrial Pressure (RAP) or Central Venous Pressure (CVP), peripheral venous pressure (PVP), Heart rate * Using a Swan-Ganz catheter: Cardiac Output, Pulmonary Artery Pressure (PAP), mixed venous (pulmonary artery) saturation and Pulmonary Wedge Pressure (PWP) * Clinical measures: Body weight, serum electrolytes, sodium, potassium, BNP/NT-proBNP, blood pressure, length of hospital stay. * Medical HF therapy including need for intensification of therapy (e.g., mechanical ventilation/therapy, circulatory support with inotropes, use of vasodilators). Clinical and observational measures 7 days, 30 & 60 days after treatment: * Clinical manifestations of worsening or persistent heart failure as defined by at least one of the following: new, persistent or worsening dyspnea, orthopnea, pulmonary basilar rales/crackles, jugular venous distension. * Re-hospitalization | — |
Countries
Netherlands
Outcome results
None listed