High power ablation
ProcedureHigh power ablation parameters (50-55 W)
NCT Number: NCT04657705
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Heart and Vascular Center, Bad Bevensen, Germany
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High power ablation parameters (50-55 W)
Standard ablation power parameters (40-45 W)
Time frame: Day 1
The number of intraoperative complications (death, hemopericardium, stroke, heart attack, electrical storm, vascular complications)
Time frame: Day 1
The number of patients with inducible VT at the end of the ablation procedure
Time frame: Up to one year
The number of recurrent ventricular tachycardias on one-year follow-up period after single procedure
Time frame: Up to one year
The number of episodes of ICD therapy on one-year follow-up period after single procedure
Time frame: 3 months
Time to the first episode of VT on 3 months follow-up period after single procedure
Time frame: Up to one year
The total time of ablation procedure
Time frame: Up to one year
The total time of fluoroscopy
Time frame: Up to one year
The total number of RF exposures
Time frame: Up to one year
The total time of RF exposures
Time frame: Up to one year
All-cause mortality (Time to any death occurring at any time on one-year follow-up period )
Time frame: Up to one year
The number of redo ablation procedures for recurrent VT on one-year follow-up period
Time frame: Up to one year
The number of appropriate and unappropriated ICD therapies
Time frame: Up to one year
The number of antiarrhythmic drugs on one-year follow-up period
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Other Gov
Application of High Power Radio Frequency Energy in the Interventional Treatment of Patients With Ventricular Tachycardia and Structural Heart Disease
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