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

Heart Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04657705
• Other study ID #: BURN VT
• Status: Completed
• Phase: N/A
• Start date: December 5, 2020
• Est. completion date: January 27, 2023

Study information

• Verified date: January 2023
• Source: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: January 27, 2023
• Est. primary completion date: January 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Procedure:
• High power ablation
High power ablation parameters (50-55 W)
• Standard ablation power
Standard ablation power parameters (40-45 W)

Locations

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

Sponsors (7)

Lead Sponsor	Collaborator
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia	Heart and Vascular Center Bad Bevensen, Germany, I.M. Sechenov First Moscow State Medical University, Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation, National Research Center of Surgery, Russia, Texas Cardiac Arrhythmia Institute, Austin, Texas

Countries where clinical trial is conducted

United States,  Germany,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of intraoperative complications	The number of intraoperative complications (death, hemopericardium, stroke, heart attack, electrical storm, vascular complications)	Day 1
Primary	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
Primary	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
Primary	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	Freedom from recurrent VT	Time to the first episode of VT on 3 months follow-up period after single procedure	3 months
Secondary	The total time of ablation procedure	The total time of ablation procedure	Up to one year
Secondary	The total time of fluoroscopy	The total time of fluoroscopy	Up to one year
Secondary	The total number of RF exposures	The total number of RF exposures	Up to one year
Secondary	The total time of RF exposures	The total time of RF exposures	Up to one year
Secondary	All-cause mortality	All-cause mortality (Time to any death occurring at any time on one-year follow-up period )	Up to one year
Secondary	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
Secondary	The number of appropriate and unappropriated ICD therapies	The number of appropriate and unappropriated ICD therapies	Up to one year
Secondary	The number of antiarrhythmic drugs	The number of antiarrhythmic drugs on one-year follow-up period	Up to one year