Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation

NCT ID: NCT07201506

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-02

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ablation of Arrhythmias Premature Ventricular Contractions Ventricular Tachycardia Ventricular Arrhythmia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Use of SOUNDSTAR® ICE Catheter

Use of SOUNDSTAR® ICE Catheter for premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation

Group Type EXPERIMENTAL

PVC and VT ablation with ICE

Intervention Type DEVICE

Premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation with intracardiac echocardiography (ICE)

Usual Care: no use of SOUNDSTAR® ICE Catheter

Usual Care: No use of SOUNDSTAR® ICE Catheter for premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation

Group Type ACTIVE_COMPARATOR

PVC and VT ablation without ICE

Intervention Type DEVICE

Premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation without intracardiac echocardiography (ICE)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PVC and VT ablation with ICE

Premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation with intracardiac echocardiography (ICE)

Intervention Type DEVICE

PVC and VT ablation without ICE

Premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation without intracardiac echocardiography (ICE)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Bern

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Basel

Basel, , Switzerland

Site Status

Inselspital, Bern University Hospital

Bern, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Boldizsar Kovacs, MD

Role: CONTACT

+41 31 664 03 84

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Patrick Badertscher, MD

Role: primary

+41 61 556 58 23

Boldizsar Kovacs, MD

Role: primary

+41 31 664 03 84

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REAL-ICE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ventricular Tachycardia Cohort
NCT07149701 NOT_YET_RECRUITING