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

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

Completed

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Key information

Conditions

Acute Heart Failure

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Onze-Lieve-Vrouwziekenhuis Aalst, Aalst, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

AHF subjects with poor diuretic response

Exclusion criteria

AHF subjects with sufficient diuretic response

Treatment and study plan

Doraya catheter

Device

Temporary deployment of the Doraya catheter in AHF patients.

Primary outcomes

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

Time frame: 60 days

SAE as defined by ISO 14155

Sponsors and collaborators

Lead sponsor

Revamp Medical Ltd.

Industry

Registry information

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Jul 31, 2017
Registry last updated: May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed