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

Not Applicable

Completed

• Conditions: Acute Heart Failure
• Interventions: Device: Doraya catheter

• Registration Number: NCT03234647
• Lead Sponsor: Revamp Medical Ltd.

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.

Study Timeline

• Study First Submitted: 2017-07-19
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-31
• Study Start: 2018-01-01
• Status Verified: 2018-09
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• AHF subjects with poor diuretic response

Exclusion Criteria

• AHF subjects with sufficient diuretic response

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AHF patients	Doraya catheter	AHF patient treatment with the Doraya catheter

Primary Outcome Measures

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

Trial Locations

Locations (7)

Onze-Lieve-Vrouwziekenhuis Aalst; 🇧🇪 Aalst, Belgium

ZNA Middelheim; 🇧🇪 Antwerpen, Belgium

Rambam Health Care Campus; 🇮🇱 Haifa, Israel

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel

Śląski Uniwersytet Medyczny w Katowicach; 🇵🇱 Katowice, Poland

4th Military; 🇵🇱 Wrocław, Poland

University Hospital; 🇵🇱 Wrocław, Poland