NCT03234647

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

May 6, 2021

Status Verified

September 1, 2018

Enrollment Period

3.3 years

First QC Date

July 19, 2017

Last Update Submit

May 4, 2021

Conditions

Acute Heart Failure

Outcome Measures

Primary Outcomes (1)

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

    SAE as defined by ISO 14155

    60 days

Study Arms (1)

AHF patients

EXPERIMENTAL

AHF patient treatment with the Doraya catheter

Device: Doraya catheter

Interventions

Doraya catheterDEVICE

Temporary deployment of the Doraya catheter in AHF patients.

AHF patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AHF subjects with poor diuretic response

You may not qualify if:

  • AHF subjects with sufficient diuretic response

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Onze-Lieve-Vrouwziekenhuis Aalst

Aalst, Belgium

Location

ZNA Middelheim

Antwerp, Belgium

Location

Rambam Health Care Campus

Haifa, Israel

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Śląski Uniwersytet Medyczny w Katowicach

Katowice, Poland

Location

4th Military

Wroclaw, Poland

Location

University Hospital

Wroclaw, Poland

Location

Related Publications (1)

  • 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.

    PMID: 37138800DERIVED

Study Officials

  • Tal Hasin, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2017

First Posted

July 31, 2017

Study Start

January 1, 2018

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

May 6, 2021

Record last verified: 2018-09

Locations

PL(3)IL(2)BE(2)