---
title: First In Human Study of the Doraya Catheter for the Treatment of AHF Patients
nct_id: NCT03234647
overall_status: COMPLETED
phase: NA
sponsor: Revamp Medical Ltd.
study_type: INTERVENTIONAL
primary_condition: Acute Heart Failure
countries: Belgium, Israel, Poland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03234647.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03234647"
ct_last_update_post_date: 2021-05-06
last_seen_at: "2026-05-12T07:30:25.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# First In Human Study of the Doraya Catheter for the Treatment of AHF Patients

**NCT ID:** [NCT03234647](https://clinicaltrials.gov/study/NCT03234647)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 9
- **Lead Sponsor:** Revamp Medical Ltd.
- **Conditions:** Acute Heart Failure
- **Start Date:** 2018-01-01
- **Completion Date:** 2021-04-30
- **CT.gov Last Update:** 2021-05-06

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* AHF subjects with poor diuretic response

Exclusion Criteria:

* AHF subjects with sufficient diuretic response
```

## Arms

- **AHF patients** (EXPERIMENTAL) — AHF patient treatment with the Doraya catheter

## Interventions

- **Doraya catheter** (DEVICE) — Temporary deployment of the Doraya catheter in AHF patients.

## Primary Outcomes

- **Device or procedure related Serious Adverse Event (SAE) rate through 60 days** _(time frame: 60 days)_ — SAE as defined by ISO 14155

## Locations (7)

- Onze-Lieve-Vrouwziekenhuis Aalst, Aalst, Belgium
- ZNA Middelheim, Antwerp, Belgium
- Rambam Health Care Campus, Haifa, Israel
- Shaare Zedek Medical Center, Jerusalem, Israel
- Śląski Uniwersytet Medyczny w Katowicach, Katowice, Poland
- 4th Military, Wroclaw, Poland
- University Hospital, Wroclaw, Poland

## Recent Field Changes (last 30 days)

- `locations.rambam health care campus|haifa||israel` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.onze-lieve-vrouwziekenhuis aalst|aalst||belgium` — added _(2026-05-12)_
- `locations.zna middelheim|antwerp||belgium` — added _(2026-05-12)_
- `locations.shaare zedek medical center|jerusalem||israel` — added _(2026-05-12)_
- `locations.śląski uniwersytet medyczny w katowicach|katowice||poland` — added _(2026-05-12)_
- `locations.4th military|wroclaw||poland` — added _(2026-05-12)_
- `locations.university hospital|wroclaw||poland` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03234647.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03234647*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*