Clinical trial NCT04657705: Application of High Power Radio Frequency Energy in the Ventricular Tachycardia Treatment
Official title: Application of High Power Radio Frequency Energy in the Interventional Treatment of Patients With Ventricular Tachycardia and Structural Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Heart Diseases
Keywords: High Power Radio Frequency Energy
Ventricular Tachycardia
Structural Heart Disease
Lead sponsor: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Sponsor class: OTHER_GOV
Collaborators: name: Meshalkin National Medical Research Center, Ministry of Health of Russian Federation
name: Heart and Vascular Center Bad Bevensen, Germany
name: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
name: National Research Center of Surgery, Russia
name: I.M. Sechenov First Moscow State Medical University
name: Texas Cardiac Arrhythmia Institute, Austin, Texas
First posted: 2020-12-08
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: The number of intraoperative complications
timeFrame: Day 1
measure: The inducibility of the clinical VT at the end of ablation procedure
timeFrame: Day 1
measure: The number of recurrent ventricular tachycardias
timeFrame: Up to one year
measure: The number of episodes of ICD therapy
timeFrame: Up to one year
Secondary outcomes:
measure: Freedom from recurrent VT
timeFrame: 3 months
measure: The total time of ablation procedure
timeFrame: Up to one year
measure: The total time of fluoroscopy
timeFrame: Up to one year
measure: The total number of RF exposures
timeFrame: Up to one year
measure: The total time of RF exposures
timeFrame: Up to one year
measure: All-cause mortality
timeFrame: Up to one year
measure: The number of redo ablation procedures for recurrent VT
timeFrame: Up to one year
measure: The number of appropriate and unappropriated ICD therapies
timeFrame: Up to one year
measure: The number of antiarrhythmic drugs
timeFrame: Up to one year
Other outcomes:
Locations:
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Institute
state: Texas
city: Bad Bevensen
country: Germany
facility: Heart and Vascular Center
city: Moscow
country: Russian Federation
facility: Federal Research Clinical Center of Federal Medical & Biological Agency
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Surgery named after A. Vishnevsky
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Cardiology
city: Novosibirsk
country: Russian Federation
facility: Meshalkin National Medical Research Center
Study officials:
affiliation: Federal Research Clinical Center FMBA Russia
name: Sergey V. Korolev, MD
role: PRINCIPAL_INVESTIGATOR
References: