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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-05

Study Completion Date

2023-01-27

Brief Summary

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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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Detailed Description

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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

Conditions

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Ventricular Tachycardia Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High power ablation

High power ablation parameters (50-55 W)

Group Type EXPERIMENTAL

High power ablation

Intervention Type PROCEDURE

High power ablation parameters (50-55 W)

Standard ablation power

Standard ablation power parameters (40-45 W)

Group Type ACTIVE_COMPARATOR

Standard ablation power

Intervention Type PROCEDURE

Standard ablation power parameters (40-45 W)

Interventions

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High power ablation

High power ablation parameters (50-55 W)

Intervention Type PROCEDURE

Standard ablation power

Standard ablation power parameters (40-45 W)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients after myocardial infarction (at least 3 months before enrollment in the study)
2. Stable, documented, monomorphic VT, confirmed by ECG and / or CMECG and / or EGM of any implanted device, having appropriate rhythm discrimination algorithms
3. Patients who have signed the informed consent

Exclusion Criteria

1. Acute myocardial ischemia
2. A reversible cause of VT (e.g. drug arrhythmia), recently(up to 30 days) suffered from acute coronary syndrome, coronary revascularization (\<90 days for bypass surgery, \<30 days for percutaneous coronary intervention), or having functional class IV angina.
3. Thrombosis of the left ventricle
4. Patients who have been implanted the mechanical prostheses in the aortic and mitral positions.
5. Patients who have been performed the catheter RFA for VT.
6. Renal failure (creatinine clearance \<15 ml / min),
7. Patients with NYHA functional class IV heart failure
8. Patients with a medical condition that may limit survival to less than 1 year
9. Patients with myocardial infarction with ST-segment elevation or MI without ST-segment elevation, transferred less than 30 days ago.
10. Patients who haven't signed the informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No