Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome

Completed

Conditions studied: Brugada Syndrome, Arrhythmogenic Right Ventricular Cardiomyopathy

In brief

The study aims to use flecainide infusion test as diagnostic test to unmask concealed Brugada Syndrome cases. It proposes to assess the safety profile of this test in US patients and its higher sensitivity when compared to procainamide infusion (the conventional drug used in the USA). As a substudy it proposes to apply this test to early ARVC cases in order to evaluate if ECG changes similar to those seen in Brugada Syndrome could be unmasked by flecainide iv.

Key facts

Study ID

NCT02302274

Run by

NYU Langone Health

People needed

209

Starts

2010-07-01

Expected to finish

2017-07-26

Last updated by the study team

2019-04-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Type 1 Brugada Syndrome ECG
• Pregnancy
• History and/or evidence of ischemic cardiomyopathy
• Recent myocardial infarction
• Allergy or known adverse reaction to flecainide

Where it is running

• New york University, School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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