Skip to main content
OpenTrials
Completed

NCT Number: NCT04657705

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart and Vascular Center, Bad Bevensen, Germany

Loading trial locations.

About this study

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:

  • To analyze the number of intraoperative complications in both groups
  • To evaluate the number of recurrent ventricular tachycardias and the number of episodes of CDI therapy in the long-term follow-up period
  • 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
  • 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
  • To estimate all-cause mortality in both groups
  • The number of repeated ablation for recurrent VT
  • The number of justified and unfounded CDI therapies
  • To analyze the long-term burden of antiarrhythmic therapy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

High power ablation

Procedure

High power ablation parameters (50-55 W)

Standard ablation power

Procedure

Standard ablation power parameters (40-45 W)

Primary outcomes

  1. The number of intraoperative complications

    Time frame: Day 1

    The number of intraoperative complications (death, hemopericardium, stroke, heart attack, electrical storm, vascular complications)

  2. The inducibility of the clinical VT at the end of ablation procedure

    Time frame: Day 1

    The number of patients with inducible VT at the end of the ablation procedure

  3. The number of recurrent ventricular tachycardias

    Time frame: Up to one year

    The number of recurrent ventricular tachycardias on one-year follow-up period after single procedure

  4. The number of episodes of ICD therapy

    Time frame: Up to one year

    The number of episodes of ICD therapy on one-year follow-up period after single procedure

Secondary outcomes

  1. Freedom from recurrent VT

    Time frame: 3 months

    Time to the first episode of VT on 3 months follow-up period after single procedure

  2. The total time of ablation procedure

    Time frame: Up to one year

    The total time of ablation procedure

  3. The total time of fluoroscopy

    Time frame: Up to one year

    The total time of fluoroscopy

  4. The total number of RF exposures

    Time frame: Up to one year

    The total number of RF exposures

  5. The total time of RF exposures

    Time frame: Up to one year

    The total time of RF exposures

  6. All-cause mortality

    Time frame: Up to one year

    All-cause mortality (Time to any death occurring at any time on one-year follow-up period )

  7. The number of redo ablation procedures for recurrent VT

    Time frame: Up to one year

    The number of redo ablation procedures for recurrent VT on one-year follow-up period

  8. The number of appropriate and unappropriated ICD therapies

    Time frame: Up to one year

    The number of appropriate and unappropriated ICD therapies

  9. The number of antiarrhythmic drugs

    Time frame: Up to one year

    The number of antiarrhythmic drugs on one-year follow-up period

Sponsors and collaborators

Lead sponsor

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

Other Gov

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 8, 2020
Registry last updated
Jan 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.