Application of High Power Radio Frequency Energy in the Ventricular Tachycardia Treatment
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Heart Diseases
- Ventricular Tachycardia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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...
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: To analyze the number of intraoperative complications in both groups To evaluate the number of recurrent ventricular tachycardias and the number of episodes of CDI therapy in the long-term follow-up period 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 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 To estimate all-cause mortality in both groups The number of repeated ablation for recurrent VT The number of justified and unfounded CDI therapies To analyze the long-term burden of antiarrhythmic therapy
Tracking Information
- NCT #
- NCT04657705
- Collaborators
- Meshalkin National Medical Research Center, Ministry of Health of Russian Federation
- Heart and Vascular Center Bad Bevensen, Germany
- Investigators
- Principal Investigator: Sergey V. Korolev, MD Federal Research Clinical Center FMBA Russia