DORAYA-HF Early Feasibility Study

Launched by REVAMP MEDICAL INC. · Jan 11, 2022

Keywords

ClinConnect Summary

The DORAYA-HF Early Feasibility Study is a clinical trial aimed at testing a new device called the Doraya Catheter in patients who are hospitalized with acute decompensated heart failure (ADHF). This condition occurs when the heart suddenly can't pump enough blood to meet the body's needs, leading to fluid buildup and other serious symptoms. The study specifically focuses on patients who haven’t responded well to standard treatments for fluid removal and aims to assess how safe and effective the Doraya Catheter is for these individuals.

To be eligible for the trial, participants must be hospitalized with a primary diagnosis of ADHF and show signs of fluid overload, along with specific blood test results indicating heart stress. However, certain health conditions, such as very low blood pressure or recent severe heart issues, may prevent someone from joining the study. Those who participate will receive care while using the Doraya Catheter and will be monitored closely for any safety concerns or improvements in their condition. This trial is currently recruiting participants aged 65 to 74, and both men and women can join.

Gender

ALL

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.