Application of High Power Radio Frequency Energy in the Ventricular Tachycardia Treatment
Primary Purpose
Ventricular Tachycardia, Heart Diseases
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
High power ablation
Standard ablation power
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia focused on measuring High Power Radio Frequency Energy, Ventricular Tachycardia, Structural Heart Disease
Eligibility Criteria
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
Sites / Locations
- Texas Cardiac Arrhythmia Institute
- Heart and Vascular Center
- Federal Research Clinical Center of Federal Medical & Biological Agency
- National Medical Research Center of Surgery named after A. Vishnevsky
- I.M. Sechenov First Moscow State Medical University
- National Medical Research Center of Cardiology
- Meshalkin National Medical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High power ablation
Standard ablation power
Arm Description
High power ablation parameters (50-55 W)
Standard ablation power parameters (40-45 W)
Outcomes
Primary Outcome Measures
The number of intraoperative complications
The number of intraoperative complications (death, hemopericardium, stroke, heart attack, electrical storm, vascular complications)
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
The number of recurrent ventricular tachycardias
The number of recurrent ventricular tachycardias on one-year follow-up period after single procedure
The number of episodes of ICD therapy
The number of episodes of ICD therapy on one-year follow-up period after single procedure
Secondary Outcome Measures
Freedom from recurrent VT
Time to the first episode of VT on 3 months follow-up period after single procedure
The total time of ablation procedure
The total time of ablation procedure
The total time of fluoroscopy
The total time of fluoroscopy
The total number of RF exposures
The total number of RF exposures
The total time of RF exposures
The total time of RF exposures
All-cause mortality
All-cause mortality (Time to any death occurring at any time on one-year follow-up period )
The number of redo ablation procedures for recurrent VT
The number of redo ablation procedures for recurrent VT on one-year follow-up period
The number of appropriate and unappropriated ICD therapies
The number of appropriate and unappropriated ICD therapies
The number of antiarrhythmic drugs
The number of antiarrhythmic drugs on one-year follow-up period
Full Information
NCT ID
NCT04657705
First Posted
September 18, 2020
Last Updated
January 27, 2023
Sponsor
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
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
1. Study Identification
Unique Protocol Identification Number
NCT04657705
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 5, 2020 (Actual)
Primary Completion Date
January 27, 2023 (Actual)
Study Completion Date
January 27, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia, Heart Diseases
Keywords
High Power Radio Frequency Energy, Ventricular Tachycardia, Structural Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High power ablation
Arm Type
Experimental
Arm Description
High power ablation parameters (50-55 W)
Arm Title
Standard ablation power
Arm Type
Active Comparator
Arm Description
Standard ablation power parameters (40-45 W)
Intervention Type
Procedure
Intervention Name(s)
High power ablation
Intervention Description
High power ablation parameters (50-55 W)
Intervention Type
Procedure
Intervention Name(s)
Standard ablation power
Intervention Description
Standard ablation power parameters (40-45 W)
Primary Outcome Measure Information:
Title
The number of intraoperative complications
Description
The number of intraoperative complications (death, hemopericardium, stroke, heart attack, electrical storm, vascular complications)
Time Frame
Day 1
Title
The inducibility of the clinical VT at the end of ablation procedure
Description
The number of patients with inducible VT at the end of the ablation procedure
Time Frame
Day 1
Title
The number of recurrent ventricular tachycardias
Description
The number of recurrent ventricular tachycardias on one-year follow-up period after single procedure
Time Frame
Up to one year
Title
The number of episodes of ICD therapy
Description
The number of episodes of ICD therapy on one-year follow-up period after single procedure
Time Frame
Up to one year
Secondary Outcome Measure Information:
Title
Freedom from recurrent VT
Description
Time to the first episode of VT on 3 months follow-up period after single procedure
Time Frame
3 months
Title
The total time of ablation procedure
Description
The total time of ablation procedure
Time Frame
Up to one year
Title
The total time of fluoroscopy
Description
The total time of fluoroscopy
Time Frame
Up to one year
Title
The total number of RF exposures
Description
The total number of RF exposures
Time Frame
Up to one year
Title
The total time of RF exposures
Description
The total time of RF exposures
Time Frame
Up to one year
Title
All-cause mortality
Description
All-cause mortality (Time to any death occurring at any time on one-year follow-up period )
Time Frame
Up to one year
Title
The number of redo ablation procedures for recurrent VT
Description
The number of redo ablation procedures for recurrent VT on one-year follow-up period
Time Frame
Up to one year
Title
The number of appropriate and unappropriated ICD therapies
Description
The number of appropriate and unappropriated ICD therapies
Time Frame
Up to one year
Title
The number of antiarrhythmic drugs
Description
The number of antiarrhythmic drugs on one-year follow-up period
Time Frame
Up to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergey V. Korolev, MD
Organizational Affiliation
Federal Research Clinical Center FMBA Russia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Cardiac Arrhythmia Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
Facility Name
Heart and Vascular Center
City
Bad Bevensen
Country
Germany
Facility Name
Federal Research Clinical Center of Federal Medical & Biological Agency
City
Moscow
ZIP/Postal Code
115682
Country
Russian Federation
Facility Name
National Medical Research Center of Surgery named after A. Vishnevsky
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
I.M. Sechenov First Moscow State Medical University
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
National Medical Research Center of Cardiology
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Meshalkin National Medical Research Center
City
Novosibirsk
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no current plan to share individual participant data (IPD).
Learn more about this trial
Application of High Power Radio Frequency Energy in the Ventricular Tachycardia Treatment
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