Tolerability and Safety of CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients with Cardio Renal Syndrome with Severe Renal Impairment

NARecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

August 26, 2022

Primary Completion Date

August 26, 2026

Study Completion Date

August 26, 2027

Conditions
Heart FailureRenal Insufficiency
Interventions
DEVICE

Implantation of the CARDIOMEMS™ HF device

The initial routine workup includes a nephrological evaluation: mGFR with Iohexol before fitting the CARDIOMEMS™ HF device, renal echo-Doppler, urinary sedimentation, etiological assessment of severe Chronic Kidney Disease, NT-ProBNP, impedancemetry, urinary ionogram, weight, anemia assessment, and correction of possible iron and/or vitamin deficiency and a cardiology evaluation: blood pressure, heart rate, clinical data, biology (Complete Blood Count, iono, urea, creatinine, total bilirubin, ferritin, CST), echocardiography (Left Ventricle Ejection Fraction, E/A, E/e', indexed volume of the left atrium, Tricuspid Annular Plane Systolic Excursion, Tissue Doppler S-wave, surface area of the right atrium, Systolic Pulmonary Artery Pressure, Right Atrial Pressure). The device will be implanted in the selected patients by Pr François Roubille at Montpellier University Hospital within 1 month of the pre-inclusion visit. It will monitor their pulmonary artery pressure.

Trial Locations (2)

30029

RECRUITING

Centre Hospitalier Universitaire de Nîmes, Nîmes

34295

RECRUITING

CHRU de Montpellier - Hôpital Arnaud de Villeneuve, Montpellier

All Listed Sponsors
collaborator

CHU Arnaud de Villeneuve MONTPELLIER

UNKNOWN

lead

Centre Hospitalier Universitaire de Nīmes

OTHER