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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
9529 Reveal XT Implantable Cardiac Monitor as well as the use of 9539 Reveal XT Patient Assistant.
Standard of care arm including exam, ECG and Holter every 6 months, and an Echo, Chest X-Ray and Stress test every 12 months.
Hospital General de Agudos "Juan Fernandez"
Buenos Aires, Buenos Aires F.D., Argentina
Hospital Interzonal General de Agudos "General José de San Martin"
La Plata, Argentina
Fundacion Cardioinfantil
Bogotá, Colombia
Hospital Militar Central
Bogotá, Colombia
To compare the time to the physician's decision to treat for electrical disorders (brady/tachyarrhythmias) between the two randomized groups.
The primary endpoint is time to the first decision to implant a device (IPG, CRT-P, ICD or CRT-D) or prescribe anti-arrhythmic drugs.
Time frame: 36 months
Summarize the recorded arrhythmic events stored within the ICM (bradyarrhythmia and tachyarrhythmia.
Compute summary statistics for arrhythmic events recorded during follow-up, whether or not related to symptoms, for all patients in the ICM arm, including the total number, distribution (e.g., minimum, maximum, median, quartiles, and standard deviation), number per patient year, number of patients having events and percentage of patients having events. Summary statistics for bradyarrhythmia and tachyarrhythmia events will also be computed separately.
Time frame: 36 months
Compute the time duration spent in arrhythmias for ICM patients.
Compute the total duration each ICM patient spends in, 1) atrial arrhythmias and 2) ventricular arrhythmias during the entire follow-up period, and their corresponding distribution (e.g., minimum, maximum, median, quartiles, standard deviation). Compute the average duration each patient spends in an, 1) atrial arrhythmia event, and 2) a ventricular arrhythmia event, and the corresponding distributions.
Time frame: 36 months
Compute the incidence of symptomatic arrhythmias in patients with an ICM
Compute the incidence rate of symptomatic arrhythmias in patients with an ICM, overall, and for bradyarrhythmias and tachyarrhythmias separately.
Time frame: 36 months
Compare the time to the physician's decision to treat with components of the composite primary endpoint between randomization arms.
Individually compare the time to the physicians' decision to treat with the following between the two randomization arms: * A device of any type (IPG, CRT-P, ICD or CRT-D) * A pacemaker (IPG) * Anti-arrhythmic drug therapy * A defibrillator (ICD or CRT-D) or prescribe anti-arrhythmic drug therapy
Time frame: 36 months
Compare the mortality rate between randomization arms.
Compare the mortality rate between randomization arms.
Time frame: 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.