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

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ClinicalTrials.gov Identifier: NCT03572881
Recruitment Status : Not yet recruiting
First Posted : June 28, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 [ Time Frame: 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).



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Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572881


Contacts
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Contact: Philippe CHEVALIER, MD PhD, Pr 4 72 35 70 27 ext +33 philippe.morel@chu-lyon.fr
Contact: Elodie MOREL, CRA 4 72 35 73 81 ext +33 elodie.morel01@chu-lyon.fr

Locations
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France
Hopital Louis Pradel
Bron, France
Contact: Philippe Chevalier, Pr    4 72 35 70 27 ext +33    philippe.chevalier@chu-lyon.fr   
Contact: Elodie Morel, CRA    4 72 35 73 81 ext +33    elodie.morel01@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03572881    
Other Study ID Numbers: 69HCL18_0279
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Brugada syndrome
ventricular arrhythmia
sudden death
Additional relevant MeSH terms:
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Brugada Syndrome
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Genetic Diseases, Inborn