First In Human Study of the Doraya Catheter for the Treatment of AHF Patients

Revamp Medical Ltd.9 enrolled

Overview

Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.

The purpose of this clinical investigation is to evaluate the safety and performance of the Doraya catheter in patients admitted with AHF, presenting persistent volume over load and poor response to diuretic treatment.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Heart Failure

Interventions

Doraya catheterDEVICE

Temporary deployment of the Doraya catheter in AHF patients.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * AHF subjects with poor diuretic response Exclusion Criteria: * AHF subjects with sufficient diuretic response

Locations (7)

Onze-Lieve-Vrouwziekenhuis Aalst

Aalst, Belgium

ZNA Middelheim

Antwerp, Belgium

Rambam Health Care Campus

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Outcomes

Primary Outcomes

Device or procedure related Serious Adverse Event (SAE) rate through 60 days

SAE as defined by ISO 14155

Time frame: 60 days

Data from ClinicalTrials.gov

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