Rhythmic Risk of Type 1 Brugada Syndrome and Pulmonary Infundibulum Mapping

NCT ID: NCT03572881

Last Updated: 2018-06-28

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2019-01-31

Brief Summary

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Brugada syndrome has been described as the association of a right bundle block with ST segment elevation on the V1 to V3 electrocardiogram in patients with a structurally normal heart. The rhythmic risk is thus difficult to evaluate in asymptomatic patients in whom the rate of events is estimated at 0.2 to 1.4% of events per year. In addition, the predictive value of ventricular pacing remains controversial; There is therefore currently no review to effectively assess rhythmic risk in patients with Brugada type I syndrome.

Investigators aimed to show a difference in pulmonary infundibulum voltage mapping in symptomatic and asymptomatic patients with Brugada type 1 syndrome with a comparable ECG.

The mapping of the pulmonary infundibulum will be performed during electrophysiological exploration. Only the catheter used differs from the usual procedure.

Detailed Description

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Conditions

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Brugada Syndrome Type 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Asymptomatic

Group Type EXPERIMENTAL

Endocardial mapping

Intervention Type DEVICE

An endocardial mapping of the pulmonary infundibulum will be performed during the electrophysiological exploration between asymptomatic patients with Brugada type 1 and patients with symptomatic Brugada type 1.

Symptomatic

Group Type EXPERIMENTAL

Endocardial mapping

Intervention Type DEVICE

An endocardial mapping of the pulmonary infundibulum will be performed during the electrophysiological exploration between asymptomatic patients with Brugada type 1 and patients with symptomatic Brugada type 1.

Interventions

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Endocardial mapping

An endocardial mapping of the pulmonary infundibulum will be performed during the electrophysiological exploration between asymptomatic patients with Brugada type 1 and patients with symptomatic Brugada type 1.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Group 21

* Brugada Type 1 syndrome
* Age : 50-60 years old
* Asymptomatic
* Signed informed consent

Group2

* Brugada Type 1 syndrome
* Age \>18 years old
* Implantable defibrillator
* Having received at least 1 appropriate shock or a sudden sudden death
* Signed informed consent

Groups 1 and 2

Exclusion Criteria

* Brugada Type 2 or 3 syndrome
* Contraindication to electrophysiological exploration
Minimum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopital Louis Pradel

Bron, , France

Site Status

Countries

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France

Central Contacts

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Philippe CHEVALIER, MD PhD, Pr

Role: CONTACT

4 72 35 70 27 ext. +33

Elodie MOREL, CRA

Role: CONTACT

4 72 35 73 81 ext. +33

Facility Contacts

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Philippe Chevalier, Pr

Role: primary

4 72 35 70 27 ext. +33

Elodie Morel, CRA

Role: backup

4 72 35 73 81 ext. +33

Other Identifiers

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69HCL18_0279

Identifier Type: -

Identifier Source: org_study_id

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