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.
Patients (≥18y) undergoing a premature ventricular contraction or ventricular tachycardia ablation.
Origin of ventricular arrhythmia with high likelihood in the right ventricular outflow tract (left-bundle-inferior axis, >V4 transition precordially)
Primary epicardial ablation planned
Congenital heart disease
Presence of a mechanical tricuspid valve prosthesis
Parallel
PVC and VT ablation with ICE
DevicePremature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation with intracardiac echocardiography (ICE)
PVC and VT ablation without ICE
DevicePremature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation without intracardiac echocardiography (ICE)
Total fluoroscopy time (minutes)
Total fluoroscopy time (minutes) from the start to the end of the ablation procedure of ventricular arrhythmias
Dose area product
Dose area product (cGy·cm²)
Cumulative radiation dose
Cumulative radiation dose (mGy)
Total procedure time (minutes)
Procedure start time is defined as the time of first vascular puncture (stick), and procedure end time is defined as the placement of the vascular closure suture.
Rate of acute procedural success
Defined as a reduction of premature ventricular contraction (PVC) burden by ≥80% and/or ventricular tachycardia (VT) non-inducibility or non-inducibility of clinical VT
Safety outcome: Rate of serious adverse events related to index ablation
Composite endpoint of cardiac tamponade requiring drainage, serious vascular complications requiring interventions, stroke/TIA, coronary artery injury requiring intervention, valvular injury requiring intervention, procedural atrioventricular block requiring pacemaker implantation, death after index ablation
Click on the lead sponsor to view all of their trials.
Insel Gruppe AG, University Hospital Bern
Lead sponsor
University of Bern
Collaborator
