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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Jun 20, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and tolerability of a device called CARDIOMEMS™ in patients who have both heart failure and severe kidney problems, known as cardio-renal syndrome. Heart failure affects many people, and around 40% of those with heart failure also experience kidney issues. The trial aims to see if using the CARDIOMEMS™ device, which measures pressure in the heart's pulmonary artery, can help manage these patients better and prevent hospitalizations.

To be eligible for this study, participants must have advanced heart failure (specifically, New York Heart Association class III) and have been hospitalized for heart-related issues in the past year. They also need to have severe kidney impairment, with a specific measure of kidney function below a certain level. If someone joins the study, they can expect to have the device implanted and monitored, and they will be closely observed to see how it affects their heart and kidney health. It’s important to know that certain health conditions or recent medical events may prevent someone from participating, and all participants will need to provide informed consent before starting the trial.

Gender

ALL

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\<15mm and/or SDTI\<9.5cm/s regardless of LVEF, NtproBNP\>1500 pg/ml.
• • Patient with advanced renal failure with GFR (CKD-EPI) \< 30 ml/min/1.73m2 for more than 3 months confirmed by GFR measurement (Iohexol clearance)
• • Patient with a pulmonary artery greater than 7 mm in diameter.
• • The patient has been informed of the study set-up, objectives, constraints and patient rights.
• • The patient must have given free and informed consent and signed the consent form.
• • The patient must be affiliated or a beneficiary of a health insurance plan. Precautions: if the patient is on anticoagulant therapy, an International Normalized Ratio \<1.5 is recommended before right heart catheterization and any implantation procedure
• Exclusion Criteria:
• • Patients with a contraindication to the CARDIOMEMS™ HF system (pulmonary embolism with sequelae, artery less than 7 mm, active infection).
• • Patients already on renal replacement therapy.
• • Patients with a history of acute venous thrombosis.
• • Patients unable to tolerate right heart catheterization.
• • Patients with a major cardiovascular event (i.e., myocardial infarction, stroke) within 2 months of the initial examination.
• • Patients with congenital heart disease or mechanical right heart valve(s).
• • Patients with known hypersensitivity or allergy to aspirin and/or clopidogrel.
• • Patients with a body mass index \>35. Measure the patient's chest circumference at the armpit: if the patient's chest circumference is \> 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.