Clinical Trial: Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients With Chagas Disease

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients With Chagas Disease

Brief Summary:

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.


Detailed Summary:

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.

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Medtronic Cardiac Rhythm and Heart Failure

Dates:
Date Received: February 9, 2012
Date Started: July 2013
Date Completion:
Last Updated: October 10, 2016
Last Verified: October 2016