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The study objective is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints, in ADHF patients deemed to have insufficient diuretic response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADHF patients | Experimental | ADHF patients with insufficient response to diuretics treated with the Doraya catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doraya catheter | Device | Temporary deployment of the Doraya catheter in ADHF patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | Device or procedure related SAEs rate (including MACE) based on MM adjudication. | 30 day post Doraya procedure |
| Urine Output | Change in total urine output | 24 hours pre Doraya deployment, during Doraya indwelling period, and for 24 hours after Doraya removal |
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Inclusion Criteria:
Exclusion Criteria:
Systolic blood pressure < 80 mmHg at the time of screening. 2. Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleurocentesis within past 14 days or cardiovascular intervention within past 14 days. 3. Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
4. Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.
5. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \severe regurgitation) or Severe mitral disease with planned intervention.
6. Evidence of active systemic infection documented by either one of the following: fever >38°C/100°F, or ongoing uncontrolled infection (i.e., inflammatory parameters not decreasing despite > 48 hours of antibiotic treatment).
7. Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heartcenter Dresden | Dresden | Germany | ||||
| Klinikum Fürth |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38447635 | Derived | Spring AM, Marsela E, Jorde UP. Early Experience With Devices That Reduce Kidney Vascular Afterload From the Veins. J Card Fail. 2024 Jul;30(7):961-963. doi: 10.1016/j.cardfail.2024.02.005. Epub 2024 Mar 4. No abstract available. |
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| Fürth |
| Germany |
| UKSH Universitäres Herzzentrum Lübeck | Lübeck | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | Germany |
| A.O.U Pisana Cisanello | Pisa | Italy |
| Mikulicz-Radecki University Teaching Hospital in Wrocław | Wroclaw | 50-368 | Poland |
| SUSCCH | Banská Bystrica | Slovakia |
| CINRE, s.r.o. | Bratislava | Slovakia |
| Hospital clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | Spain |