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To evaluate the effectiveness and safety of catheter ablation of frequent symptomatic PVCs in the pediatric population as first-line therapy compared with antiarrhythmic drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation | Experimental | Standard radiosurgery ablation of premature ventricular complexes using navigation system. |
|
| Control | Active Comparator | Antiarrhythmic therapy of premature ventricular complexes according to the guidlines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency catheter ablation | Procedure | Biosense Webster: NAVI-STAR ThermoCool, NAVI-STARĀ® RMT ThermoCool |
|
| Measure | Description | Time Frame |
|---|---|---|
| The presence of premature ventricular complexes ā„ 300 according to the 24-hour Holter ECG monitoring | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | 12 months | |
| Left ventricle diameter | 12 months | |
| Right ventricle diameter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander B Romanov, MD, PhD | Contact | +73833327655 | abromanov@mail.ru | |
| Igor L Mikheenko, MD | Contact | +73833327655 | igor.mikheenko@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Clinical Institute of Pediatrics, N.I. Pirogov Russian National Research Medical University | Recruiting | Moscow | Russia |
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| Metoprolol | Drug | Antiarrhythmic therapy of premature ventricular complexes Metoprolol 12-50 mg |
|
| Verapamil | Drug | Verapamil 20-240 mg |
|
| NAVI-STARĀ® RMT ThermoCool | Device |
|
| 12 months |
| Premature ventricular complexes burden according to the 24- hour Holter ECG | 12 months |
| Ventricular tachycardia according to the 24- hour Holter ECG | 12 months |
| State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation | Recruiting | Novosibirsk | 630055 | Russia |
|
| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| D008790 | Metoprolol |
| D014700 | Verapamil |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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