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

Primary Purpose

Brugada Syndrome Type 1

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endocardial mapping
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Brugada Syndrome Type 1 focused on measuring Brugada syndrome, ventricular arrhythmia, sudden death

Eligibility Criteria

18 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hopital Louis Pradel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Asymptomatic

Symptomatic

Arm Description

Outcomes

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
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).

Secondary Outcome Measures

Full Information

First Posted
June 19, 2018
Last Updated
June 19, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03572881
Brief Title
Rhythmic Risk of Type 1 Brugada Syndrome and Pulmonary Infundibulum Mapping
Acronym
SB-CARTO
Official Title
Assessment of Rhythmic Risk in Patients With Type 1 Brugada Syndrome by Pulmonary Infundibulum Mapping
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2018 (Anticipated)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brugada Syndrome Type 1
Keywords
Brugada syndrome, ventricular arrhythmia, sudden death

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Asymptomatic
Arm Type
Experimental
Arm Title
Symptomatic
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Endocardial mapping
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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).
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe CHEVALIER, MD PhD, Pr
Phone
4 72 35 70 27
Ext
+33
Email
philippe.morel@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie MOREL, CRA
Phone
4 72 35 73 81
Ext
+33
Email
elodie.morel01@chu-lyon.fr
Facility Information:
Facility Name
Hopital Louis Pradel
City
Bron
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Chevalier, Pr
Phone
4 72 35 70 27
Ext
+33
Email
philippe.chevalier@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Elodie Morel, CRA
Phone
4 72 35 73 81
Ext
+33
Email
elodie.morel01@chu-lyon.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Rhythmic Risk of Type 1 Brugada Syndrome and Pulmonary Infundibulum Mapping

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