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Brugada Syndrome Substrate Characterization and Ablation (UNCOVERBrS)

Primary Purpose

Brugada Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ablation
Sponsored by
Maria Cecilia Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brugada Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • Maria Cecilia HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

consecutive patients

Arm Description

20 patients clinically indicated for a endo-epicardial catheter-based mapping procedure for the treatment of ventricular tachycardia/ ventricular fibrillation substrate

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
November 17, 2022
Last Updated
March 23, 2023
Sponsor
Maria Cecilia Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05643209
Brief Title
Brugada Syndrome Substrate Characterization and Ablation
Acronym
UNCOVERBrS
Official Title
Brugada Syndrome Substrate Characterization and Ablation: Insights From ECG BrS Type I Pattern, Novel Prognostic Index dST-Tiso and High Density Mapping
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
May 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Cecilia Hospital

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brugada Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
consecutive patients
Arm Type
Other
Arm Description
20 patients clinically indicated for a endo-epicardial catheter-based mapping procedure for the treatment of ventricular tachycardia/ ventricular fibrillation substrate
Intervention Type
Procedure
Intervention Name(s)
ablation
Intervention Description
epicardial substrate homogenization (ablating abnormal fragmented prolonged low-frequency ventricular electrograms) in consecutive patients undergoing catheter ablation
Primary Outcome Measure Information:
Title
Percentage of patients free from any clinical ventricular arrhythmia at a 3, 6-months and 12-months follow-up from the procedure.
Description
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.
Time Frame
12-months
Secondary Outcome Measure Information:
Title
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.
Description
• Comparison among different setting of voltage map (OT vs Standard acquisition)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saverio Iacopino, MD
Phone
0545.217228
Email
siacopino@gvmnet.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saverio Iacopino, MD
Organizational Affiliation
Maria Cecilia Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Cecilia Hospital
City
Cotignola
State/Province
Ravenna
ZIP/Postal Code
48033
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saverio Iacopino, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Brugada Syndrome Substrate Characterization and Ablation

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