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Terminated
NCT05428631
Tolerability and Safety of CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients With Cardio Renal Syndrome With Severe Renal Impairment
Conditions: Heart Failure, Renal Insufficiency
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 4
Sponsor: Centre Hospitalier Universitaire de Nīmes
Location: Centre Hospitalier Universitaire de Nîmes Nîmes Gard
Summary
Renal failure is present in 40% of heart failure patients, and is one of the main comorbidities of heart failure. Follow-up with pulmonary artery pressure (PAP) monitoring has shown a reduction in mortality and frequency of hospitalization in patients with heart failure alone in the CHAMPION trial. Patients with New York Heart Association class III heart failure and a hospitalization in the previous 12 months were included in that study. They benefited from the "CardioMEMS™ HF" device with a sensor implanted in the pulmonary artery to measure PAP. According to that study, the information led to more precise and early adaptation of therapy by avoiding the onset of heart failure symptoms and reducing the number of hospitalizations. However, in that study, patients with impaired renal function (Glomerular Filtration Rate\
Eligibility Criteria
Inclusion Criteria:
* Patient with class NYHA III heart failure having been hospitalized in the previous 12 months for cardiac decompensation (the current indication for the CARDIOMEMS™ system), right heart failure or biventricular heart failure with the definition of TAPSE\ 165 cm, the sensor should not be implanted.
* Patients unable to take dual anti-platelet therapy or anticoagulant therapy for one month after implantation
* Patient hypersensitive or allergic to iohexol.
* Patient is participating in another Class I interventional study, or has participated in another interventional study within the last 3 months.
* Patient is in an exclusion period determined by a previous study.
* Patient is under guardianship, conservatorship, or conservatorship.
* The patient refuses to sign the consent form.
* It is impossible to give the patient informed information.
* The patient is pregnant or nursing.
Source: ClinicalTrials.gov (NCT05428631). StuddyBuddy aggregates publicly available trial information.