First In Human Study of the Doraya Catheter for the Treat... | NCT03234647

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

NCT03234647

Sponsor

Revamp Medical Ltd.

Status

Completed

Last Update Posted

May 6, 2021Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Acute Heart Failure

Interventions

Doraya catheter

Countries

Belgium
Israel
Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Apr 30, 2021Actual

Completion Date

Apr 30, 2021Actual

First Submitted Date

Jul 19, 2017

First Submission Date that Met QC Criteria

Jul 26, 2017

First Posted Date

Jul 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2021

Last Update Posted Date

May 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AHF patients	Experimental	AHF patient treatment with the Doraya catheter	Device: Doraya catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doraya catheter	Device	Temporary deployment of the Doraya catheter in AHF patients.	AHF patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AHF subjects with poor diuretic response

Exclusion Criteria:

AHF subjects with sufficient diuretic response

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tal Hasin, MD	Shaare Zedek Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Onze-Lieve-Vrouwziekenhuis Aalst		Aalst			Belgium
ZNA Middelheim

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37138800	Derived	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.