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| Name | Class |
|---|---|
| Meshalkin National Medical Research Center, Ministry of Health of Russian Federation | OTHER_GOV |
| Heart and Vascular Center Bad Bevensen, Germany | UNKNOWN |
| National Medical Research Center for Cardiology, Ministry of Health of Russian Federation |
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Background: Patient's freedom from VT after RFA remains non-optimal and it depends on many factors. One of them is the effective reduction of the myocardium with RF energy during the operation. The standardization of the parameters of RF will help to increase the success of the procedure.
Hypothesis: Radiofrequency ablation of ventricular tachycardias with high power parameters has comparable safety and leads to greater efficacy (absence of ventricular tachycardias and all types of cardioverter-defibrillator therapies) in the long-term compared with ablation with standard parameters in patients with structural heart disease.
Purpose: to evaluate the safety and the efficiency of ablation of ventricular tachycardia in patients with structural heart disease using high power RF energy.
Background: Patient's freedom from VT after RFA remains non-optimal and it depends on many factors. One of them is the effective reduction of the myocardium with RF energy during the operation. The standardization of the parameters of RF will help to increase the success of the procedure.
Hypothesis: Radiofrequency ablation of ventricular tachycardias with high power parameters has comparable safety and leads to greater efficacy (absence of ventricular tachycardias and all types of cardioverter-defibrillator therapies) in the long-term compared with ablation with standard parameters in patients with structural heart disease.
Purpose: to evaluate the safety and the efficiency of ablation of ventricular tachycardia in patients with structural heart disease using high power RF energy.
Tasks:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High power ablation | Experimental | High power ablation parameters (50-55 W) |
|
| Standard ablation power | Active Comparator | Standard ablation power parameters (40-45 W) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High power ablation | Procedure | High power ablation parameters (50-55 W) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The number of intraoperative complications | The number of intraoperative complications (death, hemopericardium, stroke, heart attack, electrical storm, vascular complications) | Day 1 |
| The inducibility of the clinical VT at the end of ablation procedure | The number of patients with inducible VT at the end of the ablation procedure | Day 1 |
| The number of recurrent ventricular tachycardias | The number of recurrent ventricular tachycardias on one-year follow-up period after single procedure | Up to one year |
| The number of episodes of ICD therapy | The number of episodes of ICD therapy on one-year follow-up period after single procedure | Up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from recurrent VT | Time to the first episode of VT on 3 months follow-up period after single procedure | 3 months |
| The total time of ablation procedure | The total time of ablation procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergey V. Korolev, MD | Federal Research Clinical Center FMBA Russia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Cardiac Arrhythmia Institute | Austin | Texas | 78749 | United States | ||
| Heart and Vascular Center |
There is no current plan to share individual participant data (IPD).
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| National Research Center of Surgery, Russia | OTHER_GOV |
| I.M. Sechenov First Moscow State Medical University | OTHER |
| Texas Cardiac Arrhythmia Institute, Austin, Texas | UNKNOWN |
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| Standard ablation power |
| Procedure |
Standard ablation power parameters (40-45 W) |
|
| Up to one year |
| The total time of fluoroscopy | The total time of fluoroscopy | Up to one year |
| The total number of RF exposures | The total number of RF exposures | Up to one year |
| The total time of RF exposures | The total time of RF exposures | Up to one year |
| All-cause mortality | All-cause mortality (Time to any death occurring at any time on one-year follow-up period ) | Up to one year |
| The number of redo ablation procedures for recurrent VT | The number of redo ablation procedures for recurrent VT on one-year follow-up period | Up to one year |
| The number of appropriate and unappropriated ICD therapies | The number of appropriate and unappropriated ICD therapies | Up to one year |
| The number of antiarrhythmic drugs | The number of antiarrhythmic drugs on one-year follow-up period | Up to one year |
| Bad Bevensen |
| Germany |
| Federal Research Clinical Center of Federal Medical & Biological Agency | Moscow | 115682 | Russia |
| National Medical Research Center of Surgery named after A. Vishnevsky | Moscow | 117997 | Russia |
| I.M. Sechenov First Moscow State Medical University | Moscow | 119991 | Russia |
| National Medical Research Center of Cardiology | Moscow | 121552 | Russia |
| Meshalkin National Medical Research Center | Novosibirsk | Russia |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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