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

NCT04657705 | Completed

• 1 other identifier: BURN VT
• Study Type: interventional
• Target: 119
• Locations: 3 countries
• Sites: 7

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.

Conditions

Ventricular Tachycardia; Heart Diseases

Keywords

High Power Radio Frequency Energy; Ventricular Tachycardia; Structural Heart Disease

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Freedom from recurrent VT

  3 months

• The total time of ablation procedure

  Up to one year

• The total time of fluoroscopy

  Up to one year

• The total number of RF exposures

  Up to one year

• The total time of RF exposures

  Up to one year

Study Arms (2)

High power ablation

EXPERIMENTAL

High power ablation parameters (50-55 W)

Procedure: High power ablation

Standard ablation power

ACTIVE COMPARATOR

Standard ablation power parameters (40-45 W)

Procedure: Standard ablation power

Interventions

High power ablation PROCEDURE

High power ablation parameters (50-55 W)

High power ablation

Standard ablation power PROCEDURE

Standard ablation power parameters (40-45 W)

Standard ablation power

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Acute myocardial ischemia
• 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.
• Thrombosis of the left ventricle
• Patients who have been implanted the mechanical prostheses in the aortic and mitral positions.
• Patients who have been performed the catheter RFA for VT.
• Renal failure (creatinine clearance \<15 ml / min),
• Patients with NYHA functional class IV heart failure
• Patients with a medical condition that may limit survival to less than 1 year
• Patients with myocardial infarction with ST-segment elevation or MI without ST-segment elevation, transferred less than 30 days ago.
• Patients who haven't signed the informed consent

Sponsors & Collaborators

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

Study Sites (7)

Texas Cardiac Arrhythmia Institute

Austin, Texas, 78749, United States

Location

Heart and Vascular Center

Bad Bevensen, Germany

Location

Federal Research Clinical Center of Federal Medical & Biological Agency

Moscow, 115682, Russia

Location

National Medical Research Center of Surgery named after A. Vishnevsky

Moscow, 117997, Russia

Location

I.M. Sechenov First Moscow State Medical University

Moscow, 119991, Russia

Location

National Medical Research Center of Cardiology

Moscow, 121552, Russia

Location

Meshalkin National Medical Research Center

Novosibirsk, Russia

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Heart Diseases

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sergey V. Korolev, MD

  Federal Research Clinical Center FMBA Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: December 8, 2020
• Study Start: December 5, 2020
• Primary Completion: January 27, 2023
• Study Completion: January 27, 2023
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (5); US (1); DE (1)