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Rhythmic Risk of Type 1 Brugada Syndrome and Pulmonary Infundibulum Mapping

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03572881
Acronym
SB-CARTO
Enrollment
10
Registered
2018-06-28
Start date
2018-07-31
Completion date
2019-01-31
Last updated
2018-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brugada Syndrome Type 1

Keywords

Brugada syndrome, ventricular arrhythmia, sudden death

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.

Interventions

DEVICEEndocardial 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Months to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 1Day 1The 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).

Countries

France

Contacts

Primary ContactPhilippe CHEVALIER, MD PhD, Pr
philippe.morel@chu-lyon.fr4 72 35 70 27
Backup ContactElodie MOREL, CRA
elodie.morel01@chu-lyon.fr4 72 35 73 81

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026