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

Application of High Power Radio Frequency Energy in the Interventional Treatment of Patients With Ventricular Tachycardia and Structural Heart Disease

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Ventricular Tachycardia
• Intervention / Treatment: Procedure: High power ablation; Procedure: Standard ablation power

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 Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sergey V. Korolev, MD; Phone Number: +7 916 348-76-55; Email: sergejkorolev@yandex.ru

Study Locations

• Germany
  • Bad Bevensen, Germany
    • Heart and Vascular Center
• Russian Federation
  • Moscow, Russian Federation, 115682
    • Federal Research Clinical Center of Federal Medical & Biological Agency
  • Moscow, Russian Federation, 119991
    • I.M. Sechenov First Moscow State Medical University
  • Moscow, Russian Federation, 121552
    • National Medical Research Center of Cardiology
  • Moscow, Russian Federation, 117997
    • National Medical Research Center of Surgery named after A. Vishnevsky
  • Novosibirsk, Russian Federation
    • Meshalkin National Medical Research Center
• United States
  • Texas
    • Austin, Texas, United States, 78749
      • Texas Cardiac Arrhythmia Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High power ablation; High power ablation parameters (50-55 W)	Procedure: High power ablation; High power ablation parameters (50-55 W)
Active Comparator: Standard ablation power; Standard ablation power parameters (40-45 W)	Procedure: Standard ablation power; Standard ablation power parameters (40-45 W)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of intraoperative complications	The number of intraoperative complications (death, hemopericardium, stroke, heart attack, electrical storm, vascular complications)	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	Day 1
The number of recurrent ventricular tachycardias	The number of recurrent ventricular tachycardias on one-year follow-up period after single procedure	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	Up to one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from recurrent VT	Time to the first episode of VT on 3 months follow-up period after single procedure	3 months
The total time of ablation procedure	The total time of ablation procedure	Up to one year
The total time of fluoroscopy	The total time of fluoroscopy	Up to one year
The total number of RF exposures	The total number of RF exposures	Up to one year
The total time of RF exposures	The total time of RF exposures	Up to one year
All-cause mortality	All-cause mortality (Time to any death occurring at any time on one-year follow-up period )	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	Up to one year
The number of appropriate and unappropriated ICD therapies	The number of appropriate and unappropriated ICD therapies	Up to one year
The number of antiarrhythmic drugs	The number of antiarrhythmic drugs on one-year follow-up period	Up to one year

Collaborators and Investigators

• Sponsor: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
• Collaborators: I.M. Sechenov First Moscow State Medical University; National Medical Research Center for Cardiology, Ministry of Health of Russian Federation; National Research Center of Surgery, Russia; Meshalkin National Medical Research Center, Ministry of Health of Russian Federation; Heart and Vascular Center Bad Bevensen, Germany; Texas Cardiac Arrhythmia Institute, Austin, Texas
• Investigators: Principal Investigator: Sergey V. Korolev, MD, Federal Research Clinical Center FMBA Russia

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2020
• Primary Completion (Actual): January 27, 2023
• Study Completion (Actual): January 27, 2023

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Ventricular Tachycardia; Structural Heart Disease; High Power Radio Frequency Energy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Diseases; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: BURN VT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no current plan to share individual participant data (IPD).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No