Application of High Power Radio Frequency Energy in the Ventricular

Status Completed

Clinical Trial Summary

Clinical Trial 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: 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04657705
Study type	Interventional
Source	Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Contact
Status	Completed
Phase	N/A
Start date	December 5, 2020
Completion date	January 27, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Application of High Power Radio Frequency Energy in the Ventricular Tachycardia Treatment

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms