An interventional study of PVC and VT ablation with ICE and PVC and VT ablation without ICE in Ablation of Arrhythmias, Premature Ventricular Contractions and Ventricular Tachycardia, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Diagnostic
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.
102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.
This study's planned enrollment of 70 is below the median of 84 across 58 interventional studies indexed under Ventricular Premature Complexes.
Browse Ventricular Premature Complexes studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
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Exclusion Criteria:
Use of SOUNDSTAR® ICE Catheter for premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation
Device: PVC and VT ablation with ICE
Usual Care: No use of SOUNDSTAR® ICE Catheter for premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation
Device: PVC and VT ablation without ICE
Premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation with intracardiac echocardiography (ICE)
Premature 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
Time frame: Day 0 (during procedure)
Dose area product
Dose area product (cGy·cm²)
Time frame: Day 0 (during procedure)
Cumulative radiation dose
Cumulative radiation dose (mGy)
Time frame: Day 0 (during procedure)
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.
Time frame: Day 0 (during procedure)
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
Time frame: Day 0 (during procedure)
Rate of sustained VT during follow-up
Any sustained ventricular tachycardia episode (lasting ≥30 seconds or requiring an intervention by implantable cardioverter defibrillator). Assessed by a 7-day Holter and/or an implanted cardiac device, if available.
Time frame: Day 0-90 after procedure
PVC reduction (%) during follow-up
Reduction of premature ventricular contraction (PVC) burden by ≥80%. Assessed by a 7-day Holter and/or an implanted cardiac device, if available.
Time frame: Day 0-90 after procedure
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
Time frame: Day 0-90 after procedure
Plan to share: Undecided
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