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Clinical Trials/NCT03572881
NCT03572881UnknownNot Applicable

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

Hospices Civils de Lyon1 site in 1 country10 target enrollmentStarted: July 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
10
Locations
1
Primary Endpoint
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

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Months to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Brugada Type 1 syndrome
  • •Age : 50-60 years old
  • •Asymptomatic
  • •Signed informed consent
  • •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

Arms & Interventions

Symptomatic

Experimental

Intervention: Endocardial mapping (Device)

Asymptomatic

Experimental

Intervention: Endocardial mapping (Device)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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