A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)

Exclusion Criteria

• •1. Very agitated patients
• •2. Patients with planned full anaesthesia during procedure
• •3. Patients with a life-expectancy less than one year
• •4. Patients confined to bed that are completely non-ambulatory
• •5. Known acute renal failure or known unstable renal function as evidenced by a recent increase in serum creatinine (SCr) of \> 0.5 mg/dl or \> 25% within 7 days
• •6. Iodinated contrast medium exposure within 7 days prior to procedure with change in SCr ≥ 0.1 mg/dl on two SCr measures ≥ 24 h apart
• •7. Advanced chronic kidney disease (CKD) with an eGFR \< 30 ml/min/1.73m² and/or dialysis
• •8. Current use of nephrotoxic agents (aminoglycoside antibiotics, sulfonamides, amphotericin B, or pentamidine), or an active chemotherapy agent
• •9. Acute or chronic pulmonary disease requiring oxygen therapy
• •10. Patients with known patent foramen ovale or atrial septal defect
• •11. Patients with planned nitrous oxide anaesthesia during intervention
• •12. Patients with manifest hyperthyroidism or manifest thyrotoxicosis
• •13. Known allergies or hypersensitivity to iodinated contrast media that cannot be adequately pre-treated prior to index procedure
• •14. Patients with decompensated heart failure
• •15. Patients with manifest tetany
• •16. Planned further procedure with a need for \> 10 ml of iodinated contrast medium (CM) in any location (e.g., CT scan, coronary angiography) within a period of 90 days
• •17. Any surgical procedure (except minor amputations) or intervention performed within 30 days prior to or planned within 90 days post index procedure
• •18. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) until day 30 after PVI.
• •19. Participation in other interventional trials. Exceptions are described in the trial protocol.
• •20. Suspected lack of compliance
• •21. Pregnant or nursing women