A new clinical trial is set to investigate the impact of real-time intracardiac echocardiography (ICE) in ventricular arrhythmia ablation procedures. This randomized controlled trial, sponsored by Insel Gruppe AG and the University of Bern, will compare outcomes between procedures performed with and without the use of ICE. It aims to provide evidence-based insights for medical devices used in arrhythmia management.
In this article:
What changed?
This clinical trial marks an important step in assessing the integration of ICE technology in the ablation of complex ventricular arrhythmias, including premature ventricular contractions (PVCs) and ventricular tachycardia (VT). Although currently not recruiting, this study holds potential to reshape ventricular arrhythmia treatment protocols globally.
How is the trial designed?
The randomized controlled trial will investigate two intervention groups:
- PVC and VT ablation procedures conducted with ICE technology.
- PVC and VT ablation procedures conducted without ICE technology.
Sponsors Insel Gruppe AG and the University Hospital Bern, along with the University of Bern, aim to collect data on procedural effectiveness, safety, and long-term patient outcomes.
What are the expected advantages of ICE?
Intracardiac echocardiography provides real-time imaging capabilities, which can support procedural accuracy during arrhythmia ablation. Enhanced visualization may potentially reduce complications and improve catheter placement accuracy.
Regulatory implications
Findings from this trial may provide critical data supporting the clinical performance claims of ICE technology. Such data could aid in regulatory approvals, reimbursement decisions, and incorporation into standard treatment guidelines.
Who is affected?
This trial directly impacts stakeholders across clinical, regulatory, and patient care domains:
- Regulatory teams: Data generated may influence medical device clearance pathways.
- Clinicians: Insights into procedural effectiveness may drive adoption of ICE-based methods.
- Patients: Improved procedural safety and outcomes could enhance quality of care in ventricular arrhythmia management.
Frequently Asked Questions
1. Why is ICE technology being studied?
Intracardiac echocardiography offers real-time imaging capabilities that may improve catheter-based procedures, enhancing safety and precision.
2. What conditions are being addressed in the study?
The trial focuses on premature ventricular contractions, ventricular tachycardia, and overall ventricular arrhythmia management.
3. When will recruitment begin?
As of the publication date on October 5, 2025, recruitment has not yet started.
4. Who is sponsoring the study?
The sponsors are Insel Gruppe AG (University Hospital Bern) and the University of Bern.
Conclusion
This trial represents an opportunity to advance evidence-based approaches in ventricular arrhythmia ablation. Pending recruitment and data collection, its findings could shape procedural standards, regulatory pathways, and patient outcomes.
Disclaimer
This article is for informational purposes only and should not be considered legal or regulatory advice. Professionals are advised to consult applicable guidelines and experts for specific cases.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07201506?term=medical+device