Rhythmic Risk of Type 1 Brugada Syndrome and Pulmonary Infundibulum Mapping

Brugada Syndrome Type 1 Clinical Trial

— SB-CARTO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03572881
• Other study ID #: 69HCL18_0279
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2018
• Est. completion date: January 2019

Study information

• Verified date: June 2018
• Source: Hospices Civils de Lyon
• Contact: Philippe CHEVALIER, MD PhD, Pr
• Phone: 4 72 35 70 27
• Email: philippe.morel[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Brugada Syndrome
• Brugada Syndrome Type 1
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	Hopital Louis Pradel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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