Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients With Chagas Disease
Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients With Chagas Disease
The study "Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients
 with Chagas Disease" is a prospective, multicenter, randomized study that is being conducted
 at several centers in Latin America with commercially available products.

 The primary study hypothesis is that patients with implantable cardiac monitors will have a
 shorter time to the decision to treat for electrical or arrhythmic disorders during the
 follow-up period.

 The geography includes Argentina and Colombia.
The purpose is to study the possible benefit of a superior treatment decision rate for
 cardiac arrhythmias (brady- and or/ tachyarrhythmias) using an implantable cardiac monitor
 (ICM) in patients with Chagas Disease diagnosed by serology, who are asymptomatic and/or
 minimally symptomatic. Patients that meet inclusion criteria of the study will be randomized
 to standard care or standard care plus ICM.

 Approximately half of the patients will receive an ICM. All patients will be followed for 36
 months. It is expected that the enrollment phase will last 1 year, and that the total study
 duration will be 4 years. The study is expected to end in 2017. One hundred and two patients
 are needed for 95% confidence level and 80% statistical power to be randomized into the
 study, at approximately 5 centers in Latin America. Patients will be considered enrolled once
 they have signed the Informed Consent. The following additional parameters will also be
 collected:

 -  Recorded arrhythmic events stored within the ICM (bradyarrhythmia and tachyarrhythmia)

 -  Time duration spent in arrhythmia and incidence of symptomatic arrhythmias in patients
 with an ICM.

 -  Clinical data on subject outcomes and changes in heart failure as assessed by heart
 failure hospitalizations, New York Heart Association class and mortality.
Inclusion Criteria:

 -  Have Chagas disease, confirmed by two serological tests.

 -  Provide evidence through any of the following diagnosis methods: Rest ECG, 24 hour
 Holter monitoring, electrophysiological study, stress test or loop monitoring, at
 least one electrical disorder consistent with sinus bradycardia greater than 45 and
 lower than 60 bpm, sinus arrest not greater than 2.0 seconds, second degree atrial
 sinus block, intraventricular conduction disorders such as right branch, left branch
 or a bifascicular blockage type, first degree A-V blockage, or of type I second degree
 AV Block without associated bradycardia, atrial and/or ventricular arrhythmias that do
 NOT constitute an indication for pacemaker implant, ICD or mapping and radio frequency
 ablation.

 -  Be asymptomatic or having minimal isolated unspecific symptoms not consistent with
 cardiac arrest, aborted sudden death, syncope, frequent and recurrent palpitations,
 cardiac failure, and lower extremity edema.

 -  Have ejection fraction of left ventricle >35%

 -  Be able to give his/her written informed consent.

 -  Subject should be > 21 years old.

 -  Be able to return for follow-up visits as required.

 Exclusion Criteria:

 -  Class I or II (according to AHA/HRS/ESC guidelines) indication for final implantation
 of pacemaker, ICD, or cardiac resynchronizer.

 -  Exhibit extrinsic causes of sinus dysfunction or A-V blockage.

 -  Exhibit infiltrative myocardial diseases such as tumors or associated valvular
 defects.

 -  Suffer any concurrent disease that may limit the follow up or evaluation.

 -  Suffer aftereffects of cerebral embolism.

 -  Suffer ablation or isolation of pulmonary veins previous to their inclusion in the
 study.

 -  Not being able or willing to comply with the follow-up schedule.

 -  Have previous lesions of the spinal cord or aftereffects of skull trauma.

 -  Have a record of epilepsy.

 -  Receive pharmacological treatment for other diseases that may modify the autonomic
 function.

 -  Have a record of myocardial infarction.

 -  History of alcohol abuse or drug addiction.

 -  History of emotional instability, unstable psychiatric disorders or are under
 treatment for such disorders.

 -  Have previously implanted pacemakers, cardiodefibrillators or CRT systems.

 -  Are included or intend to participate in another study of devices during the course of
 this study.

 -  Have a clinical condition that may limit life expectancy to < 36 months.

 -  Use of Antiarrhythmic drugs, except Beta Blockers