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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03234647

Enrollment

Registered

2017-07-31

Start date

2018-01-01

Completion date

2021-04-30

Last updated

2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Heart Failure

Brief summary

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

Detailed description

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.

Interventions

DEVICEDoraya catheter

Temporary deployment of the Doraya catheter in AHF patients.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* AHF subjects with poor diuretic response

Exclusion criteria

* AHF subjects with sufficient diuretic response

Design outcomes

Primary

Measure	Time frame	Description
Device or procedure related Serious Adverse Event (SAE) rate through 60 days	60 days	SAE as defined by ISO 14155

Countries

Belgium, Israel, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026