Post-approval trial to evaluate the performance of the 10F-Reitan Catheter Pump in advanced heart failure patients

Recruiting

• Conditions: Hypertensive heart disease; acute decompensated heart failure (ADHF), cardiorenal syndrome (CRS); I50.9; I42.0; I11; I25; Heart failure, unspecified; Dilated cardiomyopathy; Chronic ischaemic heart disease

• Registration Number: DRKS00013205
• Lead Sponsor: Cardiobridge GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

EF < 30%;
Cardiac index < 2.2 l/min/m2;
Informed consent;
Age between 18- 75 years old;
eGFR (MDRD) between 15 - 50 ml/min/1.73m²

Exclusion Criteria

Renal Replacement Therapy (RRT);
Isolated Right Heart Failure, CVP =25 mmHg;
Cardiogenic shock due to acute coronary syndrome (ACS);
Restrictive Cardiomyopathy;
Hypertrophic Cardiomyopathy;
Heparin-Induced Thrombocytopenia (HIT);
Pulmonary vascular hypertension with PCWP < 15 mm Hg;
Systolic pressure less than 75 mm Hg for 30 mins;
Septic Shock;
Tortuous iliac arteries (Anatomical variations) OR Inability to gain access for introducer sheath or catheterization;
Severe Peripheral arterial disease (PAD);
Aortic diseases: Previous intravascular repair/stenting of aorta/femoral arteries, Aortic dissection chronic or acute, known aortic aneurysm, known severe calcified aorta-iliac disease or peripheral vascular disease;
Descending thoracic aortic diameter < 21 mm;
Aortic or mitral valve stenosis (II or greater);
Known coagulopathy ;
Known thrombocytopenia or platelet dysfunction;
Significant blood dyscrasia, which is defined as any hematologic disorder characterized by intravascular hemolysis or associated with increased fragility of the red blood cell;
Lack of patient co-operation or no informed consent;
Pregnancy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in eGFR (based on MDRD formula) during 24 hours (Day 1) treatment with the 10F-RCP compared to baseline