Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation

NCT07201506 | Recruiting

• 1 other identifier: REAL-ICE
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Ventricular Arrhythmia; Ablation of Arrhythmias; Premature Ventricular Contractions; Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• Total fluoroscopy time (minutes)

  Total fluoroscopy time (minutes) from the start to the end of the ablation procedure of ventricular arrhythmias

  Day 0 (during procedure)

Secondary Outcomes (6)

• Dose area product

  Day 0 (during procedure)

• Cumulative radiation dose

  Day 0 (during procedure)

• Total procedure time (minutes)

  Day 0 (during procedure)

• Rate of acute procedural success

  Day 0 (during procedure)

• Rate of sustained VT during follow-up

  Day 0-90 after procedure

Other Outcomes (1)

• Safety outcome: Rate of serious adverse events related to index ablation

  Day 0-90 after procedure

Study Arms (2)

Use of SOUNDSTAR® ICE Catheter

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Interventions

PVC and VT ablation with ICE DEVICE

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

Use of SOUNDSTAR® ICE Catheter

PVC and VT ablation without ICE DEVICE

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

Usual Care: no use of SOUNDSTAR® ICE Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (≥18y) undergoing a premature ventricular contraction or ventricular tachycardia ablation.

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (2)

University Hospital Basel

Basel, 4013, Switzerland

RECRUITING

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Ventricular Premature Complexes; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia

Central Study Contacts

Boldizsar Kovacs, MD

CONTACT

+41 31 664 03 84; boldizsar.kovacs@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: March 25, 2026
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

CH (2)