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

R

Revamp Medical

Status

Completed

Conditions

Acute Heart Failure

Treatments

Device: Doraya catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT03234647
Doraya FIH Study for AHF

Details and patient eligibility

About

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

Full 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.

Enrollment

9 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • AHF subjects with poor diuretic response

Exclusion criteria

  • AHF subjects with sufficient diuretic response

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

AHF patients
Experimental group
Description:
AHF patient treatment with the Doraya catheter
Treatment:
Device: Doraya catheter

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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