SB-CARTO: Rhythmic Risk of Type 1 Brugada Syndrome and Pulmonary Infundibulum Mapping

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Unknown status

CT.gov ID

NCT03572881

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Brugada Syndrome Type 1	Device: Endocardial mapping	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Assessment of Rhythmic Risk in Patients With Type 1 Brugada Syndrome by Pulmonary Infundibulum Mapping

Anticipated Study Start Date :

Jul 1, 2018

Anticipated Primary Completion Date :

Jan 1, 2019

Anticipated Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Asymptomatic	Device: 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.
Experimental: Symptomatic	Device: 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.

Arm

Intervention/Treatment

Experimental: Asymptomatic

Device: 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.

Experimental: Symptomatic

Device: Endocardial mapping

Outcome Measures

Primary Outcome Measures

Identification of different voltage zones by endocardial mapping of the pulmonary infundibulum between asymptomatic patients with Brugada type 1 and patients with symptomatic Brugada type 1 [Day 1]
The voltage zone are defined with : measurement of unipolar and bipolar local voltage (mV) the scar surface the surface of the bordering area the surface of healthy tissue the quantification of the number of fractionated potentials and density with respect to the size of the infundibulum and the scar (if present) the analysis of the heterogeneity of the voltage (study of dispersion) analysis of propagation card velocities in sinus rhythm and ventricular pacing (mm / s) analysis of ventricular arrhythmia activation if positive ventricular pacing and good hemodynamic tolerance (focal / reentrant / reentrant macro).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Louis Pradel	Bron		France

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT03572881

Other Study ID Numbers:

69HCL18_0279

First Posted:

Jun 28, 2018

Last Update Posted:

Jun 28, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

Brugada syndrome

ventricular arrhythmia

sudden death

Additional relevant MeSH terms:

Brugada Syndrome

Syndrome

Study Results

No Results Posted as of Jun 28, 2018