Brugada SyndromeNCT05685134
Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome
A study testing Radiofrequency catheter ablation in people with Brugada Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This randomized, sham-controlled, and blinded clinical trial aims to evaluate the effects of radiofrequency catheter ablation on the phenotypic expression of patients with Brugada syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brugada Syndrome
- What is being tested?
- Radiofrequency catheter ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Nov 2020to 7 Apr 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a type 1 Brugada ECG pattern, as characterized by ST-segment elevation (≥2mm) with upward concavity associated with T-wave inversion, in at least one of the right precordial leads, positioned at the second, third or fourth intercostal space, either spontaneously or induced by a provocative test with Class I anti-arrhythmic drugs according to Vaughan Williams
- Patients clinically stable for at least six months before the enrollment
- Able to cope with follow-up visits up to one year after the intervention
- Patients who have signed the written informed consent
Who cannot join
- Pregnant women
- Patients with structural heart disease
- Patients with a known cardiac or systemic autonomic disorder
- Patients with a history of previous right ventricular outflow tract ablation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coração - InCor - HC/FMUSP
São Paulo, São Paulo, 05403-000
About this study
Official title: Electrophysiological and Clinical Effects of Subtrate-directed Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome: a Randomized, Sham-controlled, Masked Clinical Trial
This randomized, sham-controlled, and blinded clinical trial aims to evaluate the effects of radiofrequency catheter ablation on the phenotypic expression of patients with Brugada syndrome. The main questions it seeks to address are:
- What are the immediate effects of radiofrequency catheter ablation on cardiac electrophysiology?
- Is substrate-directed radiofrequency catheter ablation safe for patients with Brugada syndrome?
- Is substrate-directed epicardial radiofrequency catheter ablation effective in normalizing the electrocardiographic pattern and preventing life-threatening arrhythmic events?
Researchers will compare the ablation group with the control group to determine if there are differences in clinical and invasive markers of the disease after one year of follow-up.
Read the detailed description
Brugada syndrome (BS) is a cardiac disorder characterized by a specific electrocardiographic pattern and an increased risk of cardiac arrhythmias and sudden death. Most arrhythmic events occur during periods of rest, fever, or situations of heightened vagal activity. Over the past decade, catheter ablation has emerged as a valuable and potentially curative treatment for patients with BS. However, there is limited knowledge of its mechanisms or of its long-term effects on clinical and invasive markers.
This single-center, randomized, sham-controlled, and masked pilot study aims to investigate the impact of catheter ablation in 20 patients with Brugada syndrome. Participants will be randomly assigned to either the ablation or control group in a 1:1 allocation ratio and will be clinically monitored for at least 12 months following the intervention.
- Conditions
- Brugada Syndrome
- Being tested
- Radiofrequency catheter ablation, Sham procedure
- Keywords
- Brugada syndrome, Radiofrequency catheter ablation, Electroanatomic mapping, Invasive electrophysiological study
- Medical subject headings
- Brugada Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency catheter ablationDevice
Radiofrequency application via catheter to burn the electroanatomic substrate implicated in Brugada syndrome
Sham procedureDevice
Venous and epicardial punctions, catheter insertions, programmed electrical stimulation and electroanatomical mapping
| Study group | Role | What they receive |
|---|---|---|
| Ablation | Experimental | Radiofrequency catheter ablation of the abnormal - prolonged and fragmented - electrophysiologic substrate of Brugada syndrome Receives: Device: Radiofrequency catheter ablation |
| Control | Sham comparator | Femoral venous punctions, catheter insertion, programmed electrical stimulation and electroanatomic mapping, with a similar duration to the ablation procedure Receives: Device: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation recovery interval (ARI)
The activation recovery interval, which serves as a surrogate marker for the duration of the action potential, will be measured on both the epicardial and endocardial surfaces of the right ventricular outflow tract. This measurement will be taken from the onset of the minimum of the derivative of ventricular activation (dVdT) to the end of ventricular repolarization, following the classic methodology
Measured: First 30 minutes after the intervention
Area of abnormal electrical potentials measured in square centimeters (cm²)
Abnormal electrical potentials were defined as low-frequency electrograms (up to 100 Hz) with prolonged duration (>200 ms), fragmented patterns (more than three deflections), and late components extending beyond the QRS complex
Measured: First 30 minutes after the intervention
Secondary outcomes (10)
Local activation time
Measured by unipolar catheters placed in the epicardial and endocardial ventricular surfaces
Measured: First 30 minutes after the intervention
Maximum potential duration
Maximum length of ventricular signs on bipolar electrogram
Measured: First 30 minutes after the intervention
Induction of sustained ventricular arrhythmias by programmed electrical stimulation
Programmed electrical stimulation will be performed at two locations: the right ventricular apex and the right ventricular outflow tract, unless the patient experiences inducible ventricular tachycardia at the first site. The stimulation will use energy that is twice the diastolic threshold. Two drive cycles will be implemented: S1 at 600 ms and S1 at 430 ms. Up to two additional stimuli (S2 and S3) will be applied, with a minimum coupling time of 200 ms. A positive result from the programmed ventricular stimulation is identified if sustained ventricular fibrillation or polymorphic ventricular tachycardia is induced.
Measured: Immediately (first 30 minutes) after the intervention and again 12 months after
Acute post-procedure complications
Acute post-procedure complications were monitored over a three-day hospital stay, focusing on major events such as sustained ventricular arrhythmias, cardiac arrest, death, thromboembolic events, subxiphoid puncture accidents (significant bleeding (≥ 500 ml), or pericardial tamponade necessitating surgical intervention), and pericarditis. Diagnosis of pericarditis was based on characteristic pain, pericardial effusion, electrocardiographic findings (PR segment depression and diffuse ST-segment elevation), and elevated serum inflammatory markers.
Measured: During the first 72 hours following the intervention
Spontaneous type 1 Brugada electrocardiographic pattern in standard12 lead and superior leads electrocardiogram
Upward ST segment elevation ST-segment elevation ≥2 mm followed by a negative T wave (type 1 Brugada electrocardiographic pattern) in one or more right precordial leads V1 and/or V2 positioned in the second, third, or fourth intercostal spaces.
Measured: Up to one year after the procedure
Spontaneous type 1 Brugada electrocardiographic pattern during treadmill test
Upward ST segment elevation ST-segment elevation ≥2 mm followed by a negative T wave (type 1 Brugada electrocardiographic pattern) in one or more right precordial leads V1 and/or V2 positioned in the second, third, or fourth intercostal spaces, during treadmill test.
Measured: Up to one year after the procedure
Spontaneous type 1 Brugada electrocardiographic pattern in 12 lead 24 hour Holter monitoring
Upward ST segment elevation ST-segment elevation ≥2 mm followed by a negative T wave (type 1 Brugada electrocardiographic pattern) in one or more right precordial leads V1 and/or V2 positioned in the second, third, or fourth intercostal spaces during 12 lead 24h Holter ECG Monitoring
Measured: Up to one year after the procedure
Brugada type 1 electrocardiographic pattern induced by sodium channel blocker challenge
Upward ST-segment elevation ≥2 mm followed by a negative T wave (type 1 Brugada electrocardiographic pattern) in one or more right precordial leads V1 and/or V2 positioned in the second, third, or fourth intercostal spaces after an ajmaline challenge after an ajmaline challenge
Measured: During the electrophysiological study, conducted 12 months after the intervention
Occurrence of life threatening arrhythmic events
Occurrence of at least one of the following: arrhythmic syncope, documented sustained ventricular tachycardia or ventricular fibrillation, sudden cardiac death or appropriate implantable cardiac defibrillator therapy
Measured: At least one year after the intervention
Combined efficacy endpoint
Induced sustained ventricular arrhythmias during programmed ventricular stimulation one year after the intervention or any life-threatening events (such as arrhythmic syncope, spontaneous sustained ventricular arrhythmias, appropriate ICD therapy, or sudden arrhythmic death) throughout at least 12 months of follow-up.
Measured: At least one year after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start3 Nov 2020
- Primary completion7 Apr 2026
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brugada SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Model description
- Single-centre, randomized, sham-controlled, and masked pilot study with two parallel arms, with a 1:1 allocation ratio to ablation or control group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Principal investigator, Mauricio Ibrahim Scanavacca, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685134
- Sponsor's protocol ID
- IIS-470
- Status last verified
- May 2026
- First submitted
- 21 Dec 2022
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will be provided under proper request to the principal investigator
Publications
Pappone C, Brugada J, Vicedomini G, Ciconte G, Manguso F, Saviano M, Vitale R, Cuko A, Giannelli L, Calovic Z, Conti M, Pozzi P, Natalizia A, Crisa S, Borrelli V, Brugada R, Sarquella-Brugada G, Guazzi M, Frigiola A, Menicanti L, Santinelli V. Electrical Substrate Elimination in 135 Consecutive Patients With Brugada Syndrome. Circ Arrhythm Electrophysiol. 2017 May;10(5):e005053. doi: 10.1161/CIRCEP.117.005053.
PubMed 28500178Patocskai B, Yoon N, Antzelevitch C. Mechanisms Underlying Epicardial Radiofrequency Ablation to Suppress Arrhythmogenesis in Experimental Models of Brugada Syndrome. JACC Clin Electrophysiol. 2017 Apr;3(4):353-363. doi: 10.1016/j.jacep.2016.10.011. Epub 2016 Dec 21.
PubMed 28948234Kotake Y, Barua S, Kazi S, Virk S, Bhaskaran A, Campbell T, Bennett RG, Kumar S. Efficacy and safety of catheter ablation for Brugada syndrome: an updated systematic review. Clin Res Cardiol. 2023 Dec;112(12):1715-1726. doi: 10.1007/s00392-022-02020-3. Epub 2022 Apr 22.
PubMed 35451610
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological and Clinical Effects of Subtrate-directed Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome: a Randomized, Sham-controlled, Masked Clinical Trial
- ClinicalTrials.gov ID
- NCT05685134
- Acronym / sponsor ID
- IIS-470
- Conditions
- Brugada Syndrome
- Keywords
- Brugada syndrome, Radiofrequency catheter ablation, Electroanatomic mapping, Invasive electrophysiological study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 13 Jan 2023 (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.
This randomized, sham-controlled, and blinded clinical trial aims to evaluate the effects of radiofrequency catheter ablation on the phenotypic expression of patients with Brugada syndrome. The main questions it seeks to address are:
- What are the immediate effects of radiofrequency catheter ablation on cardiac electrophysiology?
- Is substrate-directed radiofrequency catheter ablation safe for patients with Brugada syndrome?
- Is substrate-directed epicardial radiofrequency catheter ablation effective in normalizing the electrocardiographic pattern and preventing life-threatening arrhythmic events?
Researchers will compare the ablation group with the control group to determine if there are differences in clinical and invasive markers of the disease after one year of follow-up.
Detailed description
Brugada syndrome (BS) is a cardiac disorder characterized by a specific electrocardiographic pattern and an increased risk of cardiac arrhythmias and sudden death. Most arrhythmic events occur during periods of rest, fever, or situations of heightened vagal activity. Over the past decade, catheter ablation has emerged as a valuable and potentially curative treatment for patients with BS. However, there is limited knowledge of its mechanisms or of its long-term effects on clinical and invasive markers.
This single-center, randomized, sham-controlled, and masked pilot study aims to investigate the impact of catheter ablation in 20 patients with Brugada syndrome. Participants will be randomly assigned to either the ablation or control group in a 1:1 allocation ratio and will be clinically monitored for at least 12 months following the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-centre, randomized, sham-controlled, and masked pilot study with two parallel arms, with a 1:1 allocation ratio to ablation or control group.
| Arm | Type | Receives |
|---|---|---|
| Ablation | Experimental | Device: Radiofrequency catheter ablationRadiofrequency catheter ablation of the abnormal - prolonged and fragmented - electrophysiologic substrate of Brugada syndrome |
| Control | Sham comparator | Device: Sham procedureFemoral venous punctions, catheter insertion, programmed electrical stimulation and electroanatomic mapping, with a similar duration to the ablation procedure |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a type 1 Brugada ECG pattern, as characterized by ST-segment elevation (≥2mm) with upward concavity associated with T-wave inversion, in at least one of the right precordial leads, positioned at the second, third or fourth intercostal space, either spontaneously or induced by a provocative test with Class I anti-arrhythmic drugs according to Vaughan Williams
- Patients clinically stable for at least six months before the enrollment
- Able to cope with follow-up visits up to one year after the intervention
- Patients who have signed the written informed consent
Key exclusion criteria (4 listed)
- Pregnant women
- Patients with structural heart disease
- Patients with a known cardiac or systemic autonomic disorder
- Patients with a history of previous right ventricular outflow tract ablation
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 |
|---|---|---|
| Radiofrequency catheter ablationRadiofrequency application via catheter to burn the electroanatomic substrate implicated in Brugada syndrome | Device | Ablation |
| Sham procedureVenous and epicardial punctions, catheter insertions, programmed electrical stimulation and electroanatomical mapping | Device | Control |
Primary outcome
Activation recovery interval (ARI)
Time frame: First 30 minutes after the intervention
The activation recovery interval, which serves as a surrogate marker for the duration of the action potential, will be measured on both the epicardial and endocardial surfaces of the right ventricular outflow tract. This measurement will be taken from the onset of the minimum of the derivative of ventricular activation (dVdT) to the end of ventricular repolarization, following the classic methodology
Area of abnormal electrical potentials measured in square centimeters (cm²)
Time frame: First 30 minutes after the intervention
Abnormal electrical potentials were defined as low-frequency electrograms (up to 100 Hz) with prolonged duration (>200 ms), fragmented patterns (more than three deflections), and late components extending beyond the QRS complex
10 secondary outcomes
Local activation time
Time frame: First 30 minutes after the intervention
Maximum potential duration
Time frame: First 30 minutes after the intervention
Induction of sustained ventricular arrhythmias by programmed electrical stimulation
Time frame: Immediately (first 30 minutes) after the intervention and again 12 months after
Acute post-procedure complications
Time frame: During the first 72 hours following the intervention
Spontaneous type 1 Brugada electrocardiographic pattern in standard12 lead and superior leads electrocardiogram
Time frame: Up to one year after the procedure
Spontaneous type 1 Brugada electrocardiographic pattern during treadmill test
Time frame: Up to one year after the procedure
Spontaneous type 1 Brugada electrocardiographic pattern in 12 lead 24 hour Holter monitoring
Time frame: Up to one year after the procedure
Brugada type 1 electrocardiographic pattern induced by sodium channel blocker challenge
Time frame: During the electrophysiological study, conducted 12 months after the intervention
Occurrence of life threatening arrhythmic events
Time frame: At least one year after the intervention
Combined efficacy endpoint
Time frame: At least one year after the intervention
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 28 May 2026.
- Background: PubMed 28500178Pappone C, Brugada J, Vicedomini G, Ciconte G, Manguso F, Saviano M, Vitale R, Cuko A, Giannelli L, Calovic Z, Conti M, Pozzi P, Natalizia A, Crisa S, Borrelli V, Brugada R, Sarquella-Brugada G, Guazzi M, Frigiola A, Menicanti L, Santinelli V. Electrical Substrate Elimination in 135 Consecutive Patients With Brugada Syndrome. Circ Arrhythm Electrophysiol. 2017 May;10(5):e005053. doi: 10.1161/CIRCEP.117.005053.
- Background: PubMed 28948234Patocskai B, Yoon N, Antzelevitch C. Mechanisms Underlying Epicardial Radiofrequency Ablation to Suppress Arrhythmogenesis in Experimental Models of Brugada Syndrome. JACC Clin Electrophysiol. 2017 Apr;3(4):353-363. doi: 10.1016/j.jacep.2016.10.011. Epub 2016 Dec 21.
- Background: PubMed 35451610Kotake Y, Barua S, Kazi S, Virk S, Bhaskaran A, Campbell T, Bennett RG, Kumar S. Efficacy and safety of catheter ablation for Brugada syndrome: an updated systematic review. Clin Res Cardiol. 2023 Dec;112(12):1715-1726. doi: 10.1007/s00392-022-02020-3. Epub 2022 Apr 22.
- Individual participant dataSharing planned: Yes. Data sharing will be provided under proper request to the principal investigator
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency catheter ablation in people with Brugada Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 4 inclusion and 4 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 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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. Some participants in this study may receive a placebo. 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?
Activation recovery interval (ARI) (time frame: First 30 minutes after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05685134, which also lists 3 linked publications.
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 28 May 2026.