Ablation in Brugada Syndrome for the Prevention of VF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2024-11-13

Brief Summary

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This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome.

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Detailed Description

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This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome. Since a recent non-randomized pilot study and scarce case reports documented potential clinical benefit of epicardial ablation of fragmented electrograms in the region of the right ventricular outflow tract, patients in this trial will be randomized to continued implanted cardioverter defibrillator therapy (control arm) or ablation of areas of fragmented electrograms in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy (intervention arm). A projected 92 patients in each group will be studied.

Conditions

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Brugada Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control arm

Control arm - continued implanted cardioverter defibrillator therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Arm

ablation of areas of fragmented signal in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy

Group Type ACTIVE_COMPARATOR

Catheter Ablation

Intervention Type PROCEDURE

catheter ablation of fragmented signal in the right ventricular outflow tract

Single Cross Over Arm

these patients were initially assigned to the control arm of the study. When these patients met the primary outcome of the study it is allowed for these patients to be included in the intervention arm and/or to start quinidine

Group Type OTHER

Catheter Ablation

Intervention Type PROCEDURE

catheter ablation of fragmented signal in the right ventricular outflow tract

Interventions

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Catheter Ablation

catheter ablation of fragmented signal in the right ventricular outflow tract

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* The diagnosis of Brugada syndrome is based on 2013 HRS/EHRA/APHRS Consensus document criteria
* Diagnosed symptomatic BrS with an implanted ICD within the last 5 years
* Diagnosed symptomatic BrS with an implanted ICD longer than 5 years but has at least 1 appropriate shock within the last 5 years
* The patient is legally competent, willing and able to undergo the study and signed the informed consent
* The patient is willing and able to adhere to the follow-up visit protocol

* A patient who has had a previous epicardial ablation
* A patient who is pregnant (which would exclude an ablation procedure)
* A patient with a co-morbid condition that possesses undue risk of general anesthesia or epicardial ablation
* A patient who has a history of radiation therapy on the thorax

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No