Effects of Flecainide on Cardiac Arrhythmias in ARVC Patients

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Arrhythmogenic Right Ventricular Cardiomyopathies
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who have been diagnosed with ARVC and meet 2010 Modified Task Force Criteria for ARVC as affected.
    2. Subjects with at minimum 500 VPBs on the most recent 24-hour Holter monitor recording prior to consent or after consent if a subsequent recording is required after 5 day washout following discontinuation of anti-arrhythmic medication.
    3. Subjects with functioning implanted cardioverter defibrillator with remote interrogation capability.
    4. Subjects should be on a beta-blocker including metoprolol, propranolol, atenolol, nadolol, carvedilol or bisoprolol unless contraindication to beta-blockers exists.
    5. Persons prescribed quinidine, procainamide, propafenone, disopyramide, dronedarone phenytoin, mexilitene, may be included after 5 day washout period with subsequent 24- hour Holter obtained after washout period
    6. Persons prescribed sotalol may be included after 5 day washout period during which another beta-blocker may be administered with subsequent 24-hour Holter obtained.
    7. Subject and personal physician and or cardiologist must agree not to use any antiarrhythmic medications during the 10 weeks of participation, unless needed for management of life-threatening arrhythmias
    8. All subjects must agree to use medically acceptable contraceptive measures during participation unless documented as surgically sterile or post-menopausal (no menstrual periods for more than one year).

You may not be eligible for this study if the following are true:

    1. Subjects who prescribed amiodarone or dofetilide at the time of consent.
    2. Subjects with left ventricular ejection fraction =40% by any imaging modality: echocardiography, angiography, CMRI, or cardiac nuclear test on the most recent test.
    3. Subjects with NYHA heart failure class III or IV at time of consent.
    4. Subjects with prior myocardial infarction at any time in the past.
    5. Subjects who are pacemaker dependent rhythm at the time of consent.
    6. Subjects with renal impairment (GFR <30 mL/min/m2).
    7. Subjects wtih prior diagnosis of severe hepatic impairment.
    8. Subjects who are pregnant or plan to become pregnant
    9. Subjects who are participating in any other interventional clinical trial.
    10. Subjects unwilling or unable to cooperate with the protocol
    11. Subjects who lives at such a distance from the clinic that travel for the consent visit would be unusually difficult



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