Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07201506

Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel, Basel, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PVC and VT ablation with ICE

Device

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

PVC and VT ablation without ICE

Device

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

Primary outcomes

  1. Total fluoroscopy time (minutes)

    Time frame: Day 0 (during procedure)

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

Secondary outcomes

  1. Dose area product

    Time frame: Day 0 (during procedure)

    Dose area product (cGy·cm²)

  2. Cumulative radiation dose

    Time frame: Day 0 (during procedure)

    Cumulative radiation dose (mGy)

  3. Total procedure time (minutes)

    Time frame: 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.

  4. Rate of acute procedural success

    Time frame: 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

  5. Rate of sustained VT during follow-up

    Time frame: 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.

  6. PVC reduction (%) during follow-up

    Time frame: 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.

Other outcomes

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

    Time frame: Day 0-90 after procedure

    Composite endpoint of cardiac tamponade requiring drainage, serious vascular complications requiring interventions, stroke/TIA, coronary artery injury requiring intervention, valvular injury requiring intervention, procedural atrioventricular block requiring pacemaker implantation, death after index ablation

Study contacts

Contact information is provided by the study sponsor or research team.

Boldizsar Kovacs, MD

CONTACT

[email protected]

+41 31 664 03 84

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • University of Bern

Registry information

Official study title

Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation: A Randomized Controlled Trial

Acronym: REAL-ICE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2025
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.