Real-time intracardiac ultrasound to guide ablation of ventricular arrhythmias
Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation: A Randomized Controlled Trial
It tests whether using ultrasound inside the heart during PVC or VT ablation can reduce X-ray exposure for adults having these procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Basel and 1 other locations) |
| Trial ID | NCT07201506 on ClinicalTrials.gov |
What this trial studies
This randomized controlled study compares ablation of premature ventricular contractions or ventricular tachycardia performed with real-time intracardiac echocardiography (ICE) versus standard ablation without ICE. Seventy adult participants will be randomized 1:1 to the two approaches, and procedures are performed at tertiary care centers in Bern and Basel. The primary outcome is the fluoroscopy (X-ray) time during the procedure, with secondary outcomes including safety, effectiveness of arrhythmia control, and total procedure time. ICE uses an ultrasound catheter positioned inside the heart to visualize catheters and cardiac structures without relying on continuous X-ray imaging.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for catheter ablation of premature ventricular contractions or ventricular tachycardia who meet the study's inclusion and exclusion criteria are ideal candidates.
Not a fit: Patients with arrhythmias likely originating in the right ventricular outflow tract, those planned for primary epicardial ablation, with congenital heart disease, or with a mechanical tricuspid valve are unlikely to benefit from this approach in this trial.
Why it matters
Potential benefit: If successful, this approach could substantially reduce patients' and staff's exposure to ionizing radiation during ventricular arrhythmia ablations.
How similar studies have performed: Use of intracardiac echocardiography to guide ablation has been reported to reduce fluoroscopy in observational series and single-center reports, but randomized data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basel and 1 other locations
- University Hospital Basel — Basel, Switzerland (Recruiting)
- Inselspital, Bern University Hospital — Bern, Switzerland (Recruiting)
Study contacts
- Study coordinator: Boldizsar Kovacs, MD
- Email: boldizsar.kovacs@insel.ch
- Phone: +41 31 664 03 84
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.