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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01539161
First received: February 9, 2012
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Chagas Disease
Heart Diseases
Device: Implantable Cardiac Monitor
Procedure: Standard of Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients With Chagas Disease

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Summarize the recorded arrhythmic events stored within the ICM (bradyarrhythmia and tachyarrhythmia. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Compare the mortality rate between randomization arms.


Estimated Enrollment: 102
Study Start Date: July 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • 9529 Reveal XT
  • 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

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539161

Contacts
Contact: Claudio Muratore, MD + 54 11 4898 5700 rs.medtroniccrmtrials@medtronic.com
Contact: Tyler A Bye, BS 763-505-8643 rs.medtroniccrmtrials@medtronic.com

Locations
Argentina
Hospital General de Agudos "Juan Fernandez" Not yet recruiting
Buenos Aires, Caba, Argentina
Contact: Aurora Ruiz, MD    +54 911 5722 1499    auroruiz@fibertel.com.ar   
Principal Investigator: Aurora Ruiz, MD         
Hospital Interzonal General de Agudos "General José de San Martin" Recruiting
La Plata, Argentina
Contact: Luis Medesani, MD    +54 0221 154811060      
Principal Investigator: Luis Medesani, MD         
Colombia
Fundacion Cardioinfantil Recruiting
Bogota, Colombia
Contact: Diego Rodriguez, MD         
Principal Investigator: Diego Rodriguez, MD         
Hospital Militar Central Not yet recruiting
Bogota, Colombia
Contact: Diego Vanegas, MD       diegovanegascadavid@gmail.com   
Principal Investigator: Diego Vanegas, MD         
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
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"
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01539161     History of Changes
Other Study ID Numbers: Reveal Chagas
Study First Received: February 9, 2012
Last Updated: December 3, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Chagas Disease
Chagasic
Reveal XT
Implantable Cardiac Monitor
ICM

Additional relevant MeSH terms:
Chagas Disease
Heart Diseases
Cardiovascular Diseases
Euglenozoa Infections
Parasitic Diseases
Protozoan Infections
Trypanosomiasis

ClinicalTrials.gov processed this record on October 23, 2014