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.
|Chagas Disease Heart Diseases||Device: Implantable Cardiac Monitor Procedure: Standard of Care||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients With Chagas Disease|
- To compare the time to the physician's decision to treat for electrical disorders (brady/tachyarrhythmias) between the two randomized groups. [ Time Frame: 36 months ]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.
- Summarize the recorded arrhythmic events stored within the ICM (bradyarrhythmia and tachyarrhythmia. [ Time Frame: 36 months ]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.
- Compute the time duration spent in arrhythmias for ICM patients. [ Time Frame: 36 months ]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.
- Compute the incidence of symptomatic arrhythmias in patients with an ICM [ Time Frame: 36 months ]Compute the incidence rate of symptomatic arrhythmias in patients with an ICM, overall, and for bradyarrhythmias and tachyarrhythmias separately.
- Compare the time to the physician's decision to treat with components of the composite primary endpoint between randomization arms. [ Time Frame: 36 months ]
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
- Compare the mortality rate between randomization arms. [ Time Frame: 36 months ]Compare the mortality rate between randomization arms.
|Study Start Date:||July 2013|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Reveal XT plus SOC
Standard of care treatment plus the Reveal XT Implantable Cardiac Monitor. Treatment will follow the same schedule of the standard of care arm regarding exam, ECG and Holter every 6 months, and an Echo, Chest X-Ray and Stress test every 12 months. The addition will be device interrogation at every 6 month exam. Participation will last 36 months.
Device: Implantable Cardiac Monitor
9529 Reveal XT Implantable Cardiac Monitor as well as the use of 9539 Reveal XT Patient Assistant.
Active Comparator: Standard of Care
Standard of care arm as described by exam, ECG and Holter every 6 months, and an Echo, Chest X-Ray and Stress test every 12 months. Participation will last 36 months.
Procedure: Standard of Care
Standard of care arm including exam, ECG and Holter every 6 months, and an Echo, Chest X-Ray and Stress test every 12 months.
Other Name: SOC
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539161
|Hospital General de Agudos "Juan Fernandez"|
|Buenos Aires, Caba, Argentina|
|Hospital Interzonal General de Agudos "General José de San Martin"|
|La Plata, Argentina|
|Hospital Militar Central|
|Study Chair:||Claudio Muratore, MD||Medtronic|
|Principal Investigator:||Diego Venagas, MD||Colombia|
|Study Chair:||Jose Carlos Pachon Mateos, MD||Brazil|
|Principal Investigator:||Luis Medesani, MD||Argentina - Hospital Interzonal Gernal de Agudos "General José de San Martin"|