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NCT07201506
This study is investigating whether using ultrasound directly inside the heart during ablation of heart rhythm disorders in the ventricles can reduce radiation exposure for patients. During an ablation, catheters are guided through the heart to treat the abnormal electrical signals. Usually, X-ray imaging (fluoroscopy) is used to see where the catheters are, which exposes both patients and hospital staff to radiation. The study is randomized and controlled: half of the participants will have the ablation with ultrasound inside the heart, and the other half will have the standard ablation without ultrasound during the procedure. The main goal is to compare the amount of X-ray time used during the procedure. Secondary goals are to look at safety, effectiveness, and the total procedure time. Patients with premature ventricular contractions or ventricular tachycardia can take part. A total of 70 people will be included, 35 in each group. Using ultrasound inside the heart makes it possible to see the catheters and heart structures directly, so many steps can be done without X-rays. This could make ablations safer and reduce radiation exposure. The study is being carried out at Inselspital, Bern University Hospital, and at University Hospital Basel. All steps are standardized and data are collected carefully. The results will show whether ultrasound during ablations can significantly reduce radiation and make ablations more efficient and safer.
NCT04038476
Complex procedures for treatment of cardiac arrhythmias are usually performed under deep sedation, since a quiet position of the patient is usually required over several hours and a significant risk of injury is caused by unconsciously movements of the patient. The sedative medication inhibits respiration. This can result in an increase of CO2-levels or a reduction oxygen-levels in the blood. Therefore, oxygen saturation (finger clip) is monitored continuously and the CO2-levels in the blood are evaluated every half hour. The study aims to evaluate, whether additional continuous CO2 measurement (transcutaneous CO2 monitoring) has a safety benefit for patients in sedation. Patients are randomly divided into two groups. The first group receives the previous standard monitoring and the second group additionally receives the transcutaneous CO2 measurement. After completion of the procedure, all study-relevant parameters are collected. Finally, the investigators examine whether oxygen saturation decreases or CO2-level increases could be prevented by a continuous, transcutaneous CO2 measurement.