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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-04-30

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.

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Detailed Description

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Conditions

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Acute Decompensated Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ADHF patients

ADHF patients with insufficient response to diuretics treated with the Doraya catheter

Group Type EXPERIMENTAL

Doraya catheter

Intervention Type DEVICE

Temporary deployment of the Doraya catheter in ADHF patients

Interventions

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Doraya catheter

Temporary deployment of the Doraya catheter in ADHF patients

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No