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

Study Overview
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Brief Summary
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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.

Official Title
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DORAYA-HF EU: Assessment of the Doraya Catheter for the Treatment of Volume Overload in Acute Heart Failure Patients With Insufficient Response to Diuretics

Conditions
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Acute Decompensated Heart Failure

Intervention / Treatment
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* Device: Doraya catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is hospitalized with primary diagnosis of ADHF. N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m orvBNP≥250 pg/mL. Evidence of fluid overload. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADHF patients<br>ADHF patients with insufficient response to diuretics treated with the Doraya catheter | Device: Doraya catheter<br>* Temporary deployment of the Doraya catheter in ADHF patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events | Device or procedure related SAEs rate (including MACE) based on MM adjudication. | 30 day post Doraya procedure | 
| Urine Output | Change in total urine output | 24 hours pre Doraya deployment, during Doraya indwelling period, and for 24 hours after Doraya removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHF