NCT01539161

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2013

Geographic Reach
2 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

February 9, 2012

Last Update Submit

October 10, 2016

Conditions

Chagas DiseaseHeart Diseases

Keywords

Chagas DiseaseChagasicReveal XTImplantable Cardiac MonitorICM

Outcome Measures

Primary Outcomes (1)

  • 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.

    36 months

Secondary Outcomes (5)

  • Summarize the recorded arrhythmic events stored within the ICM (bradyarrhythmia and tachyarrhythmia.

    36 months

  • Compute the time duration spent in arrhythmias for ICM patients.

    36 months

  • Compute the incidence of symptomatic arrhythmias in patients with an ICM

    36 months

  • Compare the time to the physician's decision to treat with components of the composite primary endpoint between randomization arms.

    36 months

  • Compare the mortality rate between randomization arms.

    36 months

Study Arms (2)

Reveal XT plus SOC

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

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

Interventions

Implantable Cardiac MonitorDEVICE

9529 Reveal XT Implantable Cardiac Monitor as well as the use of 9539 Reveal XT Patient Assistant.

Also known as: 9529 Reveal XT, 9539 Reveal XT Patient Assistant
Reveal XT plus SOC
Standard of CarePROCEDURE

Standard of care arm including exam, ECG and Holter every 6 months, and an Echo, Chest X-Ray and Stress test every 12 months.

Also known as: SOC
Standard of Care

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital General de Agudos "Juan Fernandez"

Buenos Aires, Buenos Aires F.D., Argentina

Location

Hospital Interzonal General de Agudos "General José de San Martin"

La Plata, Argentina

Location

Fundacion Cardioinfantil

Bogotá, Colombia

Location

Hospital Militar Central

Bogotá, Colombia

Location

MeSH Terms

Conditions

Chagas DiseaseHeart Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

TrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Claudio Muratore, MD

    Medtronic

    STUDY CHAIR

  • Diego Venagas, MD

    Colombia

    PRINCIPAL INVESTIGATOR

  • Jose Carlos Pachon Mateos, MD

    Brazil

    STUDY CHAIR

  • Luis Medesani, MD

    Argentina - Hospital Interzonal Gernal de Agudos "General José de San Martin"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2012

First Posted

February 27, 2012

Study Start

July 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

October 12, 2016

Record last verified: 2016-10

Locations

CO(2)AR(2)