The safety and feasibility evaluation of the Doraya catheter in subjects with Acute Heart Failure

Withdrawn

Conditions: congestive heart failure
with insufficient response to diuretic
10019280

Registration Number: NL-OMON46587

Lead Sponsor: Revamp Medical Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1) Subject is >18 and <85 years of age.
2) Subject is hospitalized with primary diagnosis of congestive AHF.
3) Evidence of fluid overload as indicated by 2 or more of the following criteria:
a) peripheral edema *2+
b) jugular venous distension *7 cm H2O
c) radiographic pulmonary edema or pleural effusion
d) enlarged liver or ascites
e) pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea.
4) Subject insufficiently responds to standard diuretic therapy, meeting the following criteria:
Sufficient diuretic treatment:
a) >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 <1 Kg/day in subject weight, or;
b) <1ml/kg/hour Urine output (for a duration of at least 4 hours), or;
c) IVC with no inspiratory collapse by cardiac ultrasonography
5) Brain natriuretic peptide (BNP) *400 pg/mL or N-terminal-pro-brain natriuretic peptide (NT-proBNP) *1,600 pg/ mL.
6) Subject understands the nature of the procedure and provides written informed consent prior to any study specific assessments.
7) Subject is willing and able to comply with the specified study requirements and follow-up assessments, and can be contacted by telephone.
8) Evidence of cardiac etiology as per cardiac ultrasonography.
9) IVC with no inspiratory collapse by cardiac ultrasonography.
10) Urine output <1ml/kg/hour, for minimum duration of 4 hours, preferably measured through a urinary catheter.
11) CVP>12 mmHg confirmed at the beginning or prior to the catheterization procedure.

Exclusion Criteria

1) Systolic blood pressure <90 mmHg at the time of screening.
2) Acute myocardial infarction or acute coronary syndrome within past 7 days.
3) Known LVEF < 10% by echocardiography within 1 year prior to enrolment.
4) Complex congenital heart disease (e.g. Tetralogy of Fallot subjects, single ventricle physiology).
5) Known active myocarditis, hypertrophic obstructive cardiomyopathy, constrictive pericarditis or cardiac tamponade.
6) Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis\severe regurgitation) or Severe mitral disease with planned intervention.
7) Severe renal dysfunction (eGFR <18 ml/min/1.73 m2 BSA) or subject is on chronic dialysis.
8) Subject has history of deep vein thrombosis and/or pulmonary embolism
9) Evidence of cardiogenic shock with organ hypo-perfusion.
Current or need of mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device),
10) Subject with bleeding disorder which limit the use of antiplatelet and/or anticoagulant therapy (e.g. Thrombocytopenia with platelets count <100,000, anemia with hemoglobin <9 mg/dL)
11) Subjects with a known infra-renal IVC diameter of <14mm
12) Open or infected wounds in the legs.
13) Subject is pregnant or lactating. Pregnancy confirmed by positive urine or serum test.
14) Subject with advanced liver disease or serum Albumin<2.5 g/dL
15) Evidence of active systemic infection (documented by either one of the following: fever >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-.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Primary Safety: Device or procedure related Serious Adverse Event (SAE) rate<br /><br>through 30 days post index procedure as adjudicated by a Clinical Events<br /><br>Committee (CEC).<br /><br>- Primary Feasibility: Technical success, defined as ability to position the<br /><br>device below the renal veins, to regulate the flow in the IVC using the device<br /><br>by creating a gradient pressure of at least 2 mmHg, and to withdraw the device. </p><br>

Secondary Outcome Measures