DORAYA-HF OUS Assessment of the Doraya Catheter for the Treatment of ADHF Patients With Insufficient Response to Diuretics

Launched by REVAMP MEDICAL LTD. · May 16, 2023

Keywords

ClinConnect Summary

The DORAYA-HF clinical trial is exploring a new device called the Doraya Catheter, designed to help patients with acute decompensated heart failure (ADHF) who aren't responding well to traditional diuretic medications. Diuretics are often used to help remove excess fluid from the body, but some patients may not see enough improvement. This study aims to assess how well the Doraya Catheter works and how safe it is for these patients.

To be part of the trial, participants need to be hospitalized with a primary diagnosis of ADHF, have specific levels of a hormone called NT-proBNP in their blood that indicate heart stress, and show signs of fluid overload. However, individuals with certain health issues, like very low blood pressure or severe heart conditions, won't be eligible. Those who join can expect close monitoring and care while using the Doraya Catheter to see if it helps relieve their symptoms better than diuretics alone. This trial is currently recruiting participants aged 65 to 74, and it welcomes individuals of all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is hospitalized with primary diagnosis of ADHF.
• • 2. N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m orvBNP≥250 pg/mL.
• • 3. Evidence of fluid overload.
• • 4. Subject insufficiently responds to IV diuretic therapy
• Exclusion Criteria:
• • Systolic blood pressure \< 80 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. Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
• • 4. Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.
• • 5. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \\severe regurgitation) or Severe mitral disease with planned intervention.
• • 6. 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 hours of antibiotic treatment).
• • 7. Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.