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Clinical Trials/NCT03234647
NCT03234647CompletedNot Applicable

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

Revamp Medical Ltd.7 sites in 3 countries9 target enrollmentStarted: January 1, 2018Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
9
Locations
7
Primary Endpoint
Device or procedure related Serious Adverse Event (SAE) rate through 60 days
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •AHF subjects with poor diuretic response

Exclusion Criteria

  • •AHF subjects with sufficient diuretic response

Arms & Interventions

AHF patients

Experimental

AHF patient treatment with the Doraya catheter

Intervention: Doraya catheter (Device)

Outcomes

Primary Outcomes

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

Time Frame: 60 days

SAE as defined by ISO 14155

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (7)

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