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Brugada SyndromeUNCOVERBrSNCT05643209

Brugada Syndrome Substrate Characterization and Ablation

A study testing ablation in people with Brugada Syndrome, run by Maria Cecilia Hospital at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Independent, single center, prospective study, to evaluate the efficacy, in consecutive BrS patients undergoing catheter ablation, at medium-long term follow-up after epicardial substrate homogenization. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brugada Syndrome
What is being tested?
ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
1 Feb 2023to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Symptomatic patients diagnosed with BrS-ECG pattern of types 1 and 2, both spontaneous and arising after Ajmaline tests, already implanted with an ICD.
  • Symptomatic patients are defined as those who present ≥1 documented episode of VT / VF in the 12 months prior to enrollment.
  • Patients eligible for ablation with 3D high-density mapping system in accordance with national guidelines, IFU and according to medical decision;
  • Adult patients able to provide written informed consent

Who cannot join

  • Patients unable to provide written informed consent;
  • Patients unable to guarantee their presence at future FU visits;
  • Patients who, according to medical judgment, have a life expectancy of less than 12 months;
  • Patients who have undergone cardiac ablation in the 90 days prior to enrollment.
  • Patients who have had adverse events that have not been resolved after any invasive procedure;
  • Women potentially pregnant or planning to become pregnant.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Saverio Iacopino, MD contact

0545.217228

siacopino@gvmnet.it

Italy1 site, 1 recruiting
  • Maria Cecilia Hospital

    Cotignola, Ravenna, 48033

    Saverio Iacopino, MD

    Recruiting

Other trials in Italy

About this study

Official title: Brugada Syndrome Substrate Characterization and Ablation: Insights From ECG BrS Type I Pattern, Novel Prognostic Index dST-Tiso and High Density Mapping

Independent, single center, prospective study, to evaluate the efficacy, in consecutive BrS patients undergoing catheter ablation, at medium-long term follow-up after epicardial substrate homogenization. The target area is defined collecting signals using high density and high resolution mapping with equi-spaced electrode array. The ablation of abnormal fragmented prolonged low-frequency ventricular electrograms is performed by contact force catheter.

Read the detailed description

Most of the patients with a diagnosis of Brugada syndrome (BrS) have no history of syncope or resuscitated cardiac arrest at the time of the diagnosis. Risk stratification in these patients is of utmost importance because cardiac arrest may be the presenting symptom. Individuals with a spontaneous electrocardiogram (ECG) BrS type I pattern (J-point and coved ST-segment elevation in the right precordial leads) are at higher risk of life-threating arrhythmic events than those with ECG abnormalities induced by sodium channel blocking agents. However, in the latter category, there may be subgroups of patients more exposed to the risk of arrhythmias. To date, a clear answer to this question has not yet emerged. Although controversial, programmed ventricular stimulation (PVS) is still central in the complex decision-making algorithm used to manage these lower risk BrS patients. A recent pooled analysis has confirmed the predictive role of PVS inidentifying BrS patients at increased risk of cardiac arrest6. Recently, Iacopino et al. demonstrate that the novel dST-Tiso interval >300 msec is a powerful predictor of ventricular arrhythmias inducibility (sensitivity 92% specificity 90%) in subjects with drug-induced BrS type I ECG pattern7. Radiofrequency ablation (RFA) of arrhythmogenic zones in the right ventricular epicardium has emerged over the past decade as a possible future curative treatment option for BrS. However, only a small number of studies with limited follow-up periods have reported successful results with RFA in symptomatic Brugada patients. The first to describe a successful RFA procedure in Brugada were Nademanee et al. using a selected cohort of nine high-risk patients with frequent ICD shocks for ventricular arrhythmias. More recently, Brugada et al.and Nademanee et al. described an improved technique for successful elimination of the Brugada syndrome phenotype with epicardial RFA. The mapping was performed before and after administration of flecainide/ajmaline which resulted in identification of more extensive arrhythmogenic segments in the RV epicardium beyond the RVOT.

Most recently, Iacopino et al. proposed a successful epicardial ablation of the arrhythmogenic substrate in BrS by using a novel and feasible technique with hybrid mini-thoracotomic approach and a 0-fluoroscopy strategy. The novel workflow combines both electrophysiological and surgical skills in a hybrid fashion with the aim to overcome their respective limitations.

Bipolar electrogram (BiEGM)-based substrate maps are heavily influenced by direction of a wavefront to the mapping bipole. Recently, Porta-Sanchez et al. evaluate high-resolution, orientation-independent peak-to-peak voltage (Vpp) maps obtained with an equi-spaced electrode array and omnipolar EGMs (OTEGMs), measure its beat-to-beat consistency, and assess its ability to delineate diseased areas within the myocardium compared against traditional BiEGMs on two orientations: along (AL) and across (AC) array splines and demonstrate that an equi-spaced electrode grid when combined with omnipolar methodology yielded the largest detectable bipolar-like voltage and is void of directional influences, providing reliable voltage assessment within infarcted and non-infarcted regions of the heart.

To date, there is no study that characterized the arrhythmogenic substrate of Brugada patients with the equi-spaced electrode array and omnipolar EGMs (OTEGMs) that are available nowadays.

The published studies regarding epicardial substrate ablation in Brugada patients describe an electrophysiological substrate characterized by abnormal fragmented prolonged low-frequency ventricular electrograms. We believe that the low resolution and the greater electrode dimensions of the conventional catheter can impact on both the duration and morphology of these signals.

The purpose of this study is to investigate the acute and long term efficacy of the protocol proposed which consists in ablating the abnormal fragmented prolonged low-frequency ventricular electrograms detected by equi-spaced electrode array and omnipolar EGMs (OTEGMs). Collecting and analyzing data concerning: late potential and voltage maps using different settings, vector data and speed maps, could be useful to better understand and describe the mechanism of this pathology.

In our expectation, a better definition of the abnormal substrate area dimension, could also confirm a relationship with the novel dST-Tiso interval.

Being tested
ablation
Medical subject headings
Brugada Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ablationProcedure or surgery

    epicardial substrate homogenization (ablating abnormal fragmented prolonged low-frequency ventricular electrograms) in consecutive patients undergoing catheter ablation

Study groups in NCT05643209
Study groupRoleWhat they receive
consecutive patientsOther20 patients clinically indicated for a endo-epicardial catheter-based mapping procedure for the treatment of ventricular tachycardia/ ventricular fibrillation substrate
Receives: Procedure: ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients free from any clinical ventricular arrhythmia at a 3, 6-months and 12-months follow-up from the procedure.

    The primary aim of the study is the rate of success at medium-long term follow-up after epicardial substrate homogenization (ablating abnormal fragmented prolonged low-frequency ventricular electrograms) in consecutive brugada patients undergoing catheter ablation.

    The medium-long term success of the ablation is defined in terms of percentage of patients free from any clinical ventricular arrhythmia at a 3, 6-months and 12-months follow-up from the procedure.

    Measured: 12-months

Secondary outcomes (1)
  1. Collecting and analyzing data concerning late potential and voltage maps using different settings, vector data and speed maps, could be useful to better understand and describe the mechanism of this pathology.

    • Comparison among different setting of voltage map (OT vs Standard acquisition)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2022
  2. Study start1 Feb 2023
  3. Primary completion30 May 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

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
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05643209
Sponsor's protocol ID
MCH2022-02
Acronym
UNCOVERBrS
Status last verified
Aug 2025
First submitted
17 Nov 2022
Last updated
15 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Iacopino S, Sorrenti PF, Petretta A, Colella J, Di Vilio A, Statuto G, Fabiano G, Campagna G, Peluso G, Fabiano E, Indellicati G, Brogneri S, Tremoli E, Mantovani L, Speziale G, Savini C, Tripodi A. Hybrid mini-thoracotomy for Brugada syndrome: epicardial substrate characterization and ablation-results from UNCOVER(BrS) study. Front Cardiovasc Med. 2025 Oct 28;12:1658355. doi: 10.3389/fcvm.2025.1658355. eCollection 2025.

    PubMed 41229453

Questions about this trial

What is this clinical trial studying?

A study testing ablation in people with Brugada Syndrome, run by Maria Cecilia Hospital at 1 site in Italy.

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 6 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: looking for participants now, as of the sponsor's last update on 15 Aug 2025. 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 Italy. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Saverio Iacopino, MD (0545.217228, siacopino@gvmnet.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients free from any clinical ventricular arrhythmia at a 3, 6-months and 12-months follow-up from the procedure. (time frame: 12-months). 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 NCT05643209, which also lists 1 linked publication.

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 15 Aug 2025.

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