Ablation of Arrhythmias, Premature Ventricular Contractions, Ventricular Arrhythmia, Ventricular Tachycardia
Conditions
Brief summary
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.
Interventions
DEVICEPVC and VT ablation with ICE
Premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation with intracardiac echocardiography (ICE)
DEVICEPVC and VT ablation without ICE
Premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation without intracardiac echocardiography (ICE)
Sponsors
Insel Gruppe AG, University Hospital Bern
University of Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients (≥18y) undergoing a premature ventricular contraction or ventricular tachycardia ablation.
Exclusion criteria
* 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 * Unwilling or unable to comply fully with study procedures and followup
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total fluoroscopy time (minutes) | Day 0 (during procedure) | Total fluoroscopy time (minutes) from the start to the end of the ablation procedure of ventricular arrhythmias |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose area product | Day 0 (during procedure) | Dose area product (cGy·cm²) |
| Cumulative radiation dose | Day 0 (during procedure) | Cumulative radiation dose (mGy) |
| Total procedure time (minutes) | Day 0 (during procedure) | 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 | Day 0 (during procedure) | 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 |
| Rate of sustained VT during follow-up | Day 0-90 after procedure | 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. |
| PVC reduction (%) during follow-up | Day 0-90 after procedure | Reduction of premature ventricular contraction (PVC) burden by ≥80%. Assessed by a 7-day Holter and/or an implanted cardiac device, if available. |
Countries
Switzerland
Contacts
CONTACTBoldizsar Kovacs, MD
Outcome results
None listed