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: 1. To analyze the number of intraoperative complications in both groups 2. To evaluate the number of recurrent ventricular tachycardias and the number of episodes of CDI therapy in the long-term follow-up period 3. To estimate the time of onset of the first episode of VT and the overall burden of VT in the long-term follow-up period 4. To compare the total time of surgery, fluoroscopy, the number and total time of RF exposure, as well as the ablation index in relation to the "acute" and separated efficiency of ablation in the study groups 5. To estimate all-cause mortality in both groups 6. The number of repeated ablation for recurrent VT 7. The number of justified and unfounded CDI therapies 8. To analyze the long-term burden of antiarrhythmic therapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
119
High power ablation parameters (50-55 W)
Standard ablation power parameters (40-45 W)
Texas Cardiac Arrhythmia Institute
Austin, Texas, United States
Heart and Vascular Center
Bad Bevensen, Germany
Federal Research Clinical Center of Federal Medical & Biological Agency
Moscow, Russia
National Medical Research Center of Surgery named after A. Vishnevsky
Moscow, Russia
I.M. Sechenov First Moscow State Medical University
Moscow, Russia
National Medical Research Center of Cardiology
Moscow, Russia
Meshalkin National Medical Research Center
Novosibirsk, Russia
The number of intraoperative complications
The number of intraoperative complications (death, hemopericardium, stroke, heart attack, electrical storm, vascular complications)
Time frame: 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
Time frame: Day 1
The number of recurrent ventricular tachycardias
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
The number of episodes of ICD therapy on one-year follow-up period after single procedure
Time frame: Up to one year
Freedom from recurrent VT
Time to the first episode of VT on 3 months follow-up period after single procedure
Time frame: 3 months
The total time of ablation procedure
The total time of ablation procedure
Time frame: Up to one year
The total time of fluoroscopy
The total time of fluoroscopy
Time frame: Up to one year
The total number of RF exposures
The total number of RF exposures
Time frame: Up to one year
The total time of RF exposures
The total time of RF exposures
Time frame: Up to one year
All-cause mortality
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
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
The number of appropriate and unappropriated ICD therapies
Time frame: Up to one year
The number of antiarrhythmic drugs
The number of antiarrhythmic drugs on one-year follow-up period
Time frame: Up to one year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.