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

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ClinicalTrials.gov Identifier: NCT04657705
Recruitment Status : Recruiting
First Posted : December 8, 2020
Last Update Posted : July 6, 2021
Sponsor:
Collaborators:
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation
Heart and Vascular Center Bad Bevensen, Germany
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
National Research Center of Surgery, Russia
I.M. Sechenov First Moscow State Medical University
Texas Cardiac Arrhythmia Institute, Austin, Texas
Information provided by (Responsible Party):
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Study Description
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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.


Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Heart Diseases Procedure: High power ablation Procedure: Standard ablation power Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Application of High Power Radio Frequency Energy in the Interventional Treatment of Patients With Ventricular Tachycardia and Structural Heart Disease
Actual Study Start Date : December 5, 2020
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : September 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: High power ablation
High power ablation parameters (50-55 W)
 Procedure: High power ablation
High power ablation parameters (50-55 W)
Active Comparator: Standard ablation power
Standard ablation power parameters (40-45 W)
 Procedure: Standard ablation power
Standard ablation power parameters (40-45 W)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04657705


Contacts
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Contact: Sergey V. Korolev, MD +7 916 348-76-55 sergejkorolev@yandex.ru

Locations
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United States, Texas
Texas Cardiac Arrhythmia Institute Recruiting
Austin, Texas, United States, 78749
Contact: Andrea Natale         
Germany
Heart and Vascular Center Recruiting
Bad Bevensen, Germany
Contact: Evgeny Lyan, MD         
Russian Federation
Federal Research Clinical Center of Federal Medical & Biological Agency Recruiting
Moscow, Russian Federation, 115682
Contact: Sergey V. Korolev, MD    +7 916 348-76-55    sergejkorolev@yandex.ru   
National Medical Research Center of Surgery named after A. Vishnevsky Recruiting
Moscow, Russian Federation, 117997
Contact: Amiran Revishvili         
I.M. Sechenov First Moscow State Medical University Recruiting
Moscow, Russian Federation, 119991
Contact: Alexey Tsyganov         
National Medical Research Center of Cardiology Recruiting
Moscow, Russian Federation, 121552
Contact: Oleg Sapilnikov         
Meshalkin National Medical Research Center Recruiting
Novosibirsk, Russian Federation
Contact: Alexander B. Romanov    +7 913 717-26-52    abromanov@mail.ru   
Sponsors and Collaborators
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation
Heart and Vascular Center Bad Bevensen, Germany
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
National Research Center of Surgery, Russia
I.M. Sechenov First Moscow State Medical University
Texas Cardiac Arrhythmia Institute, Austin, Texas
Investigators
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Principal Investigator: Sergey V. Korolev, MD Federal Research Clinical Center FMBA Russia
More Information
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Responsible Party: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
ClinicalTrials.gov Identifier: NCT04657705    
Other Study ID Numbers: BURN VT
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: July 6, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no current plan to share individual participant data (IPD).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia:
High Power Radio Frequency Energy
Ventricular Tachycardia
Structural Heart Disease
Additional relevant MeSH terms:
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Heart Diseases
Tachycardia
Tachycardia, Ventricular
Cardiovascular Diseases
 Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes