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

Not Applicable

Not yet recruiting

• Conditions: Ablation of Arrhythmias; Premature Ventricular Contractions; Ventricular Tachycardia; Ventricular Arrhythmia

• Registration Number: NCT07201506
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-23
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Study Start: 2026-02-02
• Primary Completion: 2027-02-02
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total fluoroscopy time (minutes)	Day 0 (during procedure)	Total fluoroscopy time (minutes) from the start to the end of the ablation procedure of ventricular arrhythmias

Secondary Outcome Measures

Name	Time	Method
Dose area product	Day 0 (during procedure)	Dose area product (cGy·cm²)
Cumulative radiation dose	Day 0 (during procedure)	Cumulative radiation dose (mGy)
Total procedure time	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.
Acute procedural success	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
Sustained VT during follow-up	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.
PVC reduction during follow-up	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.

Trial Locations

Locations (2)

University Hospital Basel; 🇨🇭 Basel, Switzerland

Inselspital, Bern University Hospital; 🇨🇭 Bern, Switzerland