Clinical trial NCT05206422: DORAYA-HF Early Feasibility Study
Official title: DORAYA-HF: Assessment of the Doraya Catheter for the Treatment of Volume Overload in Acute Heart Failure Patients with Insufficient Response to Diuretics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Decompensated Heart Failure
Keywords: ADHF
Lead sponsor: Revamp Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: INCLUSION.

1. Subject is \>18 years of age.
2. Subject is hospitalized with primary diagnosis of ADHF.
3. N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m or BNP≥250 pg/mL for body-mass index (BMI) ≤25.
4. 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
5. IVCCI \< 50% by cardiac ultrasonography or elevated CVP (or RAP) ≥12 mmHg (Invasively measured).
6. 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.
7. 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
8. 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

1. Systolic blood pressure \<90 mmHg at the time of screening.
2. Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleurocentesis within past 14 days or cardiovascular intervention within past 14 days.
3. Known LVEF \< 10% by echocardiography within 1 year prior to enrollment.
4. Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
5. Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), 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. Subject has severe renal dysfunction, defined as either eGFR \<25 ml/min/1.73 m2 BSA on admission or on renal replacement therapy.
8. Subject with advanced liver disease: either Total Bilirubin \> 4 mg/dL or Serum sodium (corrected for glucose) \< 125 mmol/L.
9. 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.
10. 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.
11. 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).
12. Subjects with a known infra-renal IVC diameter of \<16mm.
13. Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.

Primary outcomes:
measure: Serious Adverse Events
timeFrame: 30 days
measure: Urine Output
timeFrame: baseline [pre intervention] and accumulated through 24 hours [T=0-24 hours]
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General
state: California
city: San Francisco
country: United States
facility: San Francisco VA
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Weston
country: United States
facility: Cleveland Clinic
state: Florida
city: Detroit
country: United States
facility: Henry Ford
state: Michigan
city: Saint Louis
country: United States
facility: Christian Hospital
state: Missouri
city: Las Vegas
country: United States
facility: UMC of Southern Nevada
state: Nevada
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: The MetroHealth System
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart
state: Oklahoma
Study officials:
affiliation: CEO
name: Mike Favet
role: STUDY_DIRECTOR
References: