Ignite Creation Date:
2024-05-06 @ 6:22 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05643209
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2022-11-17
Brief Title:
Brugada Syndrome Substrate Characterization and Ablation
Sponsor:
Maria Cecilia Hospital
Organization:
Maria Cecilia Hospital
Study Overview
Official Title:
Brugada Syndrome Substrate Characterization and Ablation Insights From ECG BrS Type I Pattern Novel Prognostic Index dST-Tiso and High Density Mapping
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UNCOVERBrS
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 aland 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 flecainideajmaline 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None