Status:
RECRUITING
Tolerability and Safety of CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients with Cardio Renal Syndrome with Severe Renal Impairment
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Collaborating Sponsors:
CHU Arnaud de Villeneuve MONTPELLIER
Conditions:
Heart Failure
Renal Insufficiency
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 mor...
Detailed Description
There are currently 1.5 million heart failure patients in France. The high morbidity and mortality make it a major public health issue. Renal failure, present in 40% of these patients, is one of the m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 26 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05428631
Start Date
August 26 2022
End Date
August 26 2027
Last Update
December 10 2024
Active Locations (2)
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1
Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, France, 30029
2
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France, 34295