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

NCT ID: NCT03234647

Last Updated: 2021-05-06

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

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Acute 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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AHF patients

AHF patient treatment with the Doraya catheter

Group Type EXPERIMENTAL

Doraya catheter

Intervention Type DEVICE

Temporary deployment of the Doraya catheter in AHF patients.

Interventions

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Doraya catheter

Temporary deployment of the Doraya catheter in AHF patients.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* AHF subjects with poor diuretic response

Exclusion Criteria

* AHF subjects with sufficient diuretic response
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Revamp Medical Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tal Hasin, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Locations

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Onze-Lieve-Vrouwziekenhuis Aalst

Aalst, , Belgium

Site Status

ZNA Middelheim

Antwerp, , Belgium

Site Status

Rambam Health Care Campus

Haifa, , Israel

Site Status

Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Śląski Uniwersytet Medyczny w Katowicach

Katowice, , Poland

Site Status

4th Military

Wroclaw, , Poland

Site Status

University Hospital

Wroclaw, , Poland

Site Status

Countries

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Belgium Israel Poland

References

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Zymlinski R, Biegus J, Vanderheyden M, Gajewski P, Dierckx R, Bartunek J, Ponikowski P. Safety, Feasibility of Controllable Decrease of Vena Cava Pressure by Doraya Catheter in Heart Failure. JACC Basic Transl Sci. 2023 Apr 24;8(4):394-402. doi: 10.1016/j.jacbts.2023.02.010. eCollection 2023 Apr.

Reference Type DERIVED
PMID: 37138800 (View on PubMed)

Other Identifiers

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Doraya FIH Study for AHF

Identifier Type: -

Identifier Source: org_study_id

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