Ventricular TachycardiaNCT04657705
Application of High Power Radio Frequency Energy in the Ventricular Tachycardia Treatment
A study testing High power ablation and Standard ablation power in people with Ventricular Tachycardia and Heart Diseases, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Heart Diseases
- What is being tested?
- High power ablation and Standard ablation power
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 5 Dec 2020to 27 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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),
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- 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
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Russia5 sites
Federal Research Clinical Center of Federal Medical & Biological Agency
Moscow, 115682
National Medical Research Center of Surgery named after A. Vishnevsky
Moscow, 117997
I.M. Sechenov First Moscow State Medical University
Moscow, 119991
National Medical Research Center of Cardiology
Moscow, 121552
Meshalkin National Medical Research Center
Novosibirsk
United States1 site
Texas Cardiac Arrhythmia Institute
Austin, Texas, 78749
About this study
Official title: Application of High Power Radio Frequency Energy in the Interventional Treatment of Patients With Ventricular Tachycardia and Structural Heart Disease
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.
Read the 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
- Conditions
- Ventricular Tachycardia, Heart Diseases
- Being tested
- High power ablation, Standard ablation power
- Keywords
- High Power Radio Frequency Energy, Ventricular Tachycardia, Structural Heart Disease
- Medical subject headings
- Tachycardia, Ventricular, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High power ablationProcedure or surgery
High power ablation parameters (50-55 W)
Standard ablation powerProcedure or surgery
Standard ablation power parameters (40-45 W)
| Study group | Role | What they receive |
|---|---|---|
| High power ablation | Experimental | High power ablation parameters (50-55 W) Receives: Procedure: High power ablation |
| Standard ablation power | Active comparator | Standard ablation power parameters (40-45 W) Receives: Procedure: Standard ablation power |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of intraoperative complications
The number of intraoperative complications (death, hemopericardium, stroke, heart attack, electrical storm, vascular complications)
Measured: 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
Measured: Day 1
The number of recurrent ventricular tachycardias
The number of recurrent ventricular tachycardias on one-year follow-up period after single procedure
Measured: 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
Measured: Up to one year
Secondary outcomes (9)
Freedom from recurrent VT
Time to the first episode of VT on 3 months follow-up period after single procedure
Measured: 3 months
The total time of ablation procedure
The total time of ablation procedure
Measured: Up to one year
The total time of fluoroscopy
The total time of fluoroscopy
Measured: Up to one year
The total number of RF exposures
The total number of RF exposures
Measured: Up to one year
The total time of RF exposures
The total time of RF exposures
Measured: Up to one year
All-cause mortality
All-cause mortality (Time to any death occurring at any time on one-year follow-up period )
Measured: Up to one year
The number of redo ablation procedures for recurrent VT
The number of redo ablation procedures for recurrent VT on one-year follow-up period
Measured: Up to one year
The number of appropriate and unappropriated ICD therapies
The number of appropriate and unappropriated ICD therapies
Measured: Up to one year
The number of antiarrhythmic drugs
The number of antiarrhythmic drugs on one-year follow-up period
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start5 Dec 2020
- Primary completion27 Jan 2023
- Study completion27 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
- Sponsor type
- Other government
- 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
- Responsible party
- Sponsor
- Investigators
- Sergey V. Korolev, MD, Principal investigator, Federal Research Clinical Center FMBA Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657705
- Sponsor's protocol ID
- BURN VT
- Status last verified
- Jan 2023
- First submitted
- 18 Sep 2020
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual participant data (IPD).
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of High Power Radio Frequency Energy in the Interventional Treatment of Patients With Ventricular Tachycardia and Structural Heart Disease
- ClinicalTrials.gov ID
- NCT04657705
- Acronym / sponsor ID
- BURN VT
- Conditions
- Ventricular Tachycardia, Heart Diseases
- Keywords
- High Power Radio Frequency Energy, Ventricular Tachycardia, Structural Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Federal Research Clinical Center of Federal Medical & Biological Agency, RussiaOther government
- 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
- Study start
- 5 Dec 2020 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High power ablation | Experimental | Procedure: High power ablationHigh power ablation parameters (50-55 W) |
| Standard ablation power | Active comparator | Procedure: Standard ablation powerStandard ablation power parameters (40-45 W) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High power ablationHigh power ablation parameters (50-55 W) | Procedure or surgery | High power ablation |
| Standard ablation powerStandard ablation power parameters (40-45 W) | Procedure or surgery | Standard ablation power |
Primary outcome
The number of intraoperative complications
Time frame: Day 1
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
Time frame: Day 1
The number of patients with inducible VT at the end of the ablation procedure
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
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
9 secondary outcomes
Freedom from recurrent VT
Time frame: 3 months
The total time of ablation procedure
Time frame: Up to one year
The total time of fluoroscopy
Time frame: Up to one year
The total number of RF exposures
Time frame: Up to one year
The total time of RF exposures
Time frame: Up to one year
All-cause mortality
Time frame: Up to one year
The number of redo ablation procedures for recurrent VT
Time frame: Up to one year
The number of appropriate and unappropriated ICD therapies
Time frame: Up to one year
The number of antiarrhythmic drugs
Time frame: Up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: No. There is no current plan to share individual participant data (IPD).
Related trials for Ventricular Tachycardia
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VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
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Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
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Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergey V. Korolev, MD principal investigator
Federal Research Clinical Center FMBA Russia
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High power ablation and Standard ablation power in people with Ventricular Tachycardia and Heart Diseases, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Russia, United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of intraoperative complications (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.