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| Name | Class |
|---|---|
| University of Bern | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of SOUNDSTAR® ICE Catheter | Experimental | Use of SOUNDSTAR® ICE Catheter for premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVC and VT ablation with ICE | Device | Premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation with intracardiac echocardiography (ICE) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Dose area product | Dose area product (cGy·cm²) | Day 0 (during procedure) |
| Cumulative radiation dose | Cumulative radiation dose (mGy) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcome: Rate of serious adverse events related to index ablation | 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 | Day 0-90 after procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boldizsar Kovacs, MD | Contact | +41 31 664 03 84 | boldizsar.kovacs@insel.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Recruiting | Basel | 4013 | Switzerland |
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| PVC and VT ablation without ICE | Device | Premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation without intracardiac echocardiography (ICE) |
|
| 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. | 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 | 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. | 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. | Day 0-90 after procedure |
| Inselspital, Bern University Hospital | Recruiting | Bern | 3010 | Switzerland |
|
| ID | Term |
|---|---|
| D018879 | Ventricular Premature Complexes |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
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