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Recruiting NCT07201506

Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation

No phase Interventional Ablation of Arrhythmias Premature Ventricular Contractions Ventricular Tachycardia Ventricular Arrhythmia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PVC and VT ablation with ICE, PVC and VT ablation without ICE.
Who it may be relevant to
Registry conditions: Ablation of Arrhythmias, Premature Ventricular Contractions, Ventricular Tachycardia, Ventricular Arrhythmia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Total fluoroscopy time (minutes) [Time frame: Day 0 (during procedure)]
Secondary outcome measures (6)
  • Dose area product [Time frame: Day 0 (during procedure)]
  • Cumulative radiation dose [Time frame: Day 0 (during procedure)]
  • Total procedure time (minutes) [Time frame: Day 0 (during procedure)]
  • Rate of acute procedural success [Time frame: Day 0 (during procedure)]
  • Rate of sustained VT during follow-up [Time frame: Day 0-90 after procedure]
  • PVC reduction (%) during follow-up [Time frame: Day 0-90 after procedure]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Switzerland · 2 centers
  • University Hospital Basel — Basel
  • Inselspital, Bern University Hospital — Bern

Identifiers

NCT: NCT07201506 · REAL-ICE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗