Instituto do Coração - InCor - HC/FMUSP
São Paulo, 05403-000, Brazil
NCT Number: NCT05685134
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.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
São Paulo, 05403-000, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Radiofrequency application via catheter to burn the electroanatomic substrate implicated in Brugada syndrome
Venous and epicardial punctions, catheter insertions, programmed electrical stimulation and electroanatomical mapping
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
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
Time frame: First 30 minutes after the intervention
Measured by unipolar catheters placed in the epicardial and endocardial ventricular surfaces
Time frame: First 30 minutes after the intervention
Maximum length of ventricular signs on bipolar electrogram
Time frame: Immediately (first 30 minutes) after the intervention and again 12 months after
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.
Time frame: During the first 72 hours following the intervention
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.
Time frame: Up to one year after the procedure
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.
Time frame: Up to one year after the procedure
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.
Time frame: Up to one year after the procedure
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
Time frame: During the electrophysiological study, conducted 12 months after the intervention
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
Time frame: At least one year after the intervention
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
Time frame: At least one year after the intervention
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.
University of Sao Paulo General Hospital
Other
Electrophysiological and Clinical Effects of Subtrate-directed Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome: a Randomized, Sham-controlled, Masked Clinical Trial
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.
NCT04712136
Aortic Stenosis, Subvalvular, Aortic Valve Disease
Montpellier, Occitanie, France
View Trial DetailsNCT05274646
Arrhythmias, Cardiac, Brugada Syndrome
Saint-Pierre, France, Reunion
View Trial DetailsNCT03764592
Arrhythmias, Cardiac, Brugada Syndrome
Bangkok, Thailand
View Trial DetailsNCT02704416
Arrhythmias, Cardiac, Brugada Syndrome
Amsterdam, Netherlands
View Trial Details