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

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)

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9 participants in 1 patient group

AHF patients

Experimental group

Description:

AHF patient treatment with the Doraya catheter

Treatment:

Device: Doraya catheter