Clinical trial NCT01539161: Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients With Chagas Disease
Official title: Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients With Chagas Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chagas Disease
Heart Diseases
Keywords: Chagas Disease
Chagasic
Reveal XT
Implantable Cardiac Monitor
ICM
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare the time to the physician's decision to treat for electrical disorders (brady/tachyarrhythmias) between the two randomized groups.
timeFrame: 36 months
Secondary outcomes:
measure: Summarize the recorded arrhythmic events stored within the ICM (bradyarrhythmia and tachyarrhythmia.
timeFrame: 36 months
measure: Compute the time duration spent in arrhythmias for ICM patients.
timeFrame: 36 months
measure: Compute the incidence of symptomatic arrhythmias in patients with an ICM
timeFrame: 36 months
measure: Compare the time to the physician's decision to treat with components of the composite primary endpoint between randomization arms.
timeFrame: 36 months
measure: Compare the mortality rate between randomization arms.
timeFrame: 36 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos "Juan Fernandez"
state: Caba
city: La Plata
country: Argentina
facility: Hospital Interzonal General de Agudos "General José de San Martin"
city: Bogota
country: Colombia
facility: Fundacion Cardioinfantil
city: Bogota
country: Colombia
facility: Hospital Militar Central
Study officials:
affiliation: Medtronic
name: Claudio Muratore, MD
role: STUDY_CHAIR
affiliation: Colombia
name: Diego Venagas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brazil
name: Jose Carlos Pachon Mateos, MD
role: STUDY_CHAIR
affiliation: Argentina - Hospital Interzonal Gernal de Agudos "General José de San Martin"
name: Luis Medesani, MD
role: PRINCIPAL_INVESTIGATOR
References: