Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT04657705
Brief Summary:
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.
Detailed 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:
NCT04657705
Study Brief:
Protocol Section:
NCT04657705