Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome

Brugada Syndrome is an inherited arrhythmogenic disease responsible for life-threatening
arrhythmias and sudden cardiac death in young individuals with structural normal heart.

It is characterized by a peculiar ECG pattern, but this pattern could be intermittent. The
infusion of sodium channel blockers (flecainide, ajmaline, procainamide) is used to unmask a
concealed ECG pattern, thus providing an essential contribution to the diagnosis of this
condition.

In the current clinical practice in USA, only procainamide is used for diagnostic purposes;
however in Europe only ajmaline and flecainide, available as iv formulations, are widely
used. European and Japanese studies have demonstrated that the use of flecainide harbors less
risks of adverse events in patients and may have a higher accuracy in unraveling the presence
of the disease.

In the present study the investigators propose to use flecainide infusion test in the
Cardiovascular Genetics Program at NYUMC, in order to assess its sensitivity and specificity
in diagnosing the disease and compare the incidence of adverse events to that observed during
procainamide use.

Additionally, the investigators propose to extend the study protocol to patients with a
suspect diagnosis of Arrhythmogenic Right Ventricular Tachycardia (ARVC), due to the possible
overlap between the two conditions.

The study has the following aims:

1. To demonstrate the higher sensitivity and specificity of flecainide iv infusion compared
to procainamide infusion for the diagnosis of Brugada Syndrome.

2. To demonstrate that flecainide is equally safe or safer than procainamide to use for
diagnosing Brugada Syndrome.

3. To demonstrate that flecainide has high sensitivity and specificity in diagnosing also
some patients with early stage Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC).

Inclusion Criteria:

- Suspect diagnosis of Brugada Syndrome or ARVC

- Idiopathic ventricular fibrillation and suspect concealed Brugada syndrome

- Family history of Brugada Syndrome

- Family history of unexpected cardiac sudden death

Exclusion Criteria:

- Type 1 Brugada Syndrome ECG

- Pregnancy

- History and/or evidence of ischemic cardiomyopathy

- Recent myocardial infarction

- Allergy or known adverse reaction to flecainide