MedTrace Logo

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

NCT04657705 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2023-01-30

No results posted yet for this study

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

Interventions

PROCEDURE

High power ablation

High power ablation parameters (50-55 W)

PROCEDURE

Standard ablation power

Standard ablation power parameters (40-45 W)

Sponsors & Collaborators

  • Meshalkin National Medical Research Center, Ministry of Health of Russian Federation

    collaborator OTHER_GOV

  • Heart and Vascular Center Bad Bevensen, Germany

    collaborator UNKNOWN

  • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

    collaborator OTHER_GOV

  • National Research Center of Surgery, Russia

    collaborator OTHER_GOV

  • I.M. Sechenov First Moscow State Medical University

    collaborator OTHER

  • Texas Cardiac Arrhythmia Institute, Austin, Texas

    collaborator UNKNOWN

  • Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

    lead OTHER_GOV

Principal Investigators

  • Sergey V. Korolev, MD · Federal Research Clinical Center FMBA Russia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-05
Primary Completion
2023-01-27
Completion
2023-01-27

Countries

  • United States
  • Germany
  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04657705 on ClinicalTrials.gov