Ablation of ArrhythmiasREAL-ICENCT07201506
Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation
A study testing PVC and VT ablation with ICE and PVC and VT ablation without ICE in people with Ablation of Arrhythmias and Premature Ventricular Contractions, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ablation of Arrhythmias, Premature Ventricular Contractions, Ventricular Tachycardia
- What is being tested?
- PVC and VT ablation with ICE and PVC and VT ablation without ICE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 25 Mar 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (≥18y) undergoing a premature ventricular contraction or ventricular tachycardia ablation.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Basel
Basel, 4013
Patrick Badertscher, MD, +41 61 556 58 23, patrick.badertscher@usb.ch
- Recruiting
Inselspital, Bern University Hospital
Bern, 3010
Boldizsar Kovacs, MD, +41 31 664 03 84, boldizsar.kovacs@insel.ch
About this study
Official title: Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation: A Randomized Controlled Trial
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.
Read more
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
- Ablation of Arrhythmias, Premature Ventricular Contractions, Ventricular Tachycardia, Ventricular Arrhythmia
- Being tested
- PVC and VT ablation with ICE, PVC and VT ablation without ICE
- Medical subject headings
- Ventricular Premature Complexes, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVC and VT ablation with ICEDevice
Premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation with intracardiac echocardiography (ICE)
PVC and VT ablation without ICEDevice
Premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation without intracardiac echocardiography (ICE)
| Study group | Role | What they receive |
|---|---|---|
| Use of SOUNDSTAR® ICE Catheter | Experimental | Use of SOUNDSTAR® ICE Catheter for premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation Receives: 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 Receives: Device: PVC and VT ablation without ICE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fluoroscopy time (minutes)
Total fluoroscopy time (minutes) from the start to the end of the ablation procedure of ventricular arrhythmias
Measured: Day 0 (during procedure)
Secondary outcomes (6)
Dose area product
Dose area product (cGy·cm²)
Measured: Day 0 (during procedure)
Cumulative radiation dose
Cumulative radiation dose (mGy)
Measured: Day 0 (during procedure)
Total procedure time (minutes)
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.
Measured: Day 0 (during procedure)
Rate of acute procedural success
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
Measured: Day 0 (during procedure)
Rate of sustained VT during follow-up
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.
Measured: Day 0-90 after procedure
PVC reduction (%) during follow-up
Reduction of premature ventricular contraction (PVC) burden by ≥80%. Assessed by a 7-day Holter and/or an implanted cardiac device, if available.
Measured: Day 0-90 after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start25 Mar 2026
- Primary completion25 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ablation of ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201506
- Sponsor's protocol ID
- REAL-ICE
- Acronym
- REAL-ICE
- Status last verified
- Mar 2026
- First submitted
- 23 Sep 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07201506
- Acronym / sponsor ID
- REAL-ICE / REAL-ICE
- Conditions
- Ablation of Arrhythmias, Premature Ventricular Contractions, Ventricular Tachycardia, Ventricular Arrhythmia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 25 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of SOUNDSTAR® ICE Catheter | Experimental | Device: PVC and VT ablation with ICEUse of SOUNDSTAR® ICE Catheter for premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation |
| Usual Care: no use of SOUNDSTAR® ICE Catheter | Active comparator | Device: PVC and VT ablation without ICEUsual Care: No use of SOUNDSTAR® ICE Catheter for premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients (≥18y) undergoing a premature ventricular contraction or ventricular tachycardia ablation.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVC and VT ablation with ICEPremature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation with intracardiac echocardiography (ICE) | Device | Use of SOUNDSTAR® ICE Catheter |
| PVC and VT ablation without ICEPremature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation without intracardiac echocardiography (ICE) | Device | Usual Care: no use of SOUNDSTAR® ICE Catheter |
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVC and VT ablation with ICE and PVC and VT ablation without ICE in people with Ablation of Arrhythmias and Premature Ventricular Contractions, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boldizsar Kovacs, MD (+41 31 664 03 84, boldizsar.kovacs@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total fluoroscopy time (minutes) (time frame: Day 0 (during procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.