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

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

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.

Study Overview

• Status: Unknown
• Conditions: Brugada Syndrome Type 1
• Intervention / Treatment: Device: Endocardial mapping

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France
    • Hôpital Louis Pradel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	Day 1

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: ventricular arrhythmia; sudden death; Brugada syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease; Genetic Diseases, Inborn; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Syndrome; Brugada Syndrome
• Other Study ID Numbers: 69HCL18_0279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No