DORAYA-HF Early Feasibility Study

Revamp Medical

Status

Enrolling

Conditions

Acute Decompensated Heart Failure

Treatments

Device: Doraya Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT05206422

CIS-D-03

Details and patient eligibility

About

The study objective is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints, in ADHF patients deemed to have insufficient diuretic response.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION.

Subject is >18 years of age.
Subject is hospitalized with primary diagnosis of ADHF.
N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m or BNP≥250 pg/mL for body-mass index (BMI) ≤25.
Evidence of fluid overload as indicated by 2 or more of the following criteria:
1. peripheral edema ≥ 2+
2. radiographic pulmonary edema or pleural effusion
3. enlarged liver or ascites
4. pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea
5. Jugular venous distention > 7 cmH2O
IVCCI < 50% by cardiac ultrasonography or elevated CVP (or RAP) ≥12 mmHg (Invasively measured).
Subject insufficiently responds to IV diuretic therapy defined as average hourly urine output <125ml/hour over 6 hours OR cumulative urine output < 3L over 24 hours OR a Net Fluid Loss <375mL in a 12-hour timeframe following ≥2 diuretic challenges with a minimum of:
1. 1st diuretic dose: ≥2X chronic oral daily dose (IV) or 80 mg IV Lasix or equivalent.
2. 2nd diuretic dose: ≥ 80 mg IV Lasix or equivalent.
Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study. Females of child-bearing potential must have a negative pregnancy test.

Procedural Inclusion Criterion
CVP (or RAP) ≥12 mmHg and PCWP ≥ 18 mmHg confirmed in the Cath Lab, via femoral line, pigtail, Swan Ganz, or other indwelling catheter.

EXCLUSION

Systolic blood pressure <90 mmHg at the time of screening.
Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleurocentesis within past 14 days or cardiovascular intervention within past 14 days.
Known LVEF < 10% by echocardiography within 1 year prior to enrollment.
Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.
Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \severe regurgitation) or Severe mitral disease with planned intervention.
Subject has severe renal dysfunction, defined as either eGFR <25 ml/min/1.73 m2 BSA on admission or on renal replacement therapy.
Subject with advanced liver disease: either Total Bilirubin > 4 mg/dL or Serum sodium (corrected for glucose) < 125 mmol/L.
Treatment with high dose IV inotropes within 2 days prior to enrollment. High dose is defined as > 1 unit of inotrope (excluding Digoxin) as follows: 5 µg/kg/min dopamine = 1 unit, 5 µg/kg/min dobutamine= 1 unit, 0.375 µg/kg/min milrinone = 1 unit.
Subject with a history of:
1. Deep vein thrombosis that occurred < 6 months prior to enrollment, and/or;
2. Pulmonary embolism episode that occurred < 6 months prior to enrollment.
Evidence of active systemic infection documented by either one of the following: fever >38°C/100°F, or ongoing uncontrolled infection (i.e. inflammatory parameters not decreasing despite > 48 hrs of antibiotic treatment).
Subjects with a known infra-renal IVC diameter of <16mm.
Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.