Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients With Chagas Disease
This study is not yet open for participant recruitment.
Verified October 2012 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Medtronic Cardiac Rhythm Disease Management
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01539161
First received: February 9, 2012
Last updated: October 3, 2012
Last verified: October 2012
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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, Brazil 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: | September 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (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:
|
|
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 2015. 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
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 Interzonal General de Agudos "General José de San Martin" | Not yet recruiting |
| La Plata, Argentina | |
| Contact: Luis Medesani, MD +54 0221 154811060 | |
| Principal Investigator: Luis Medesani, MD | |
| Brazil | |
| Instituto Dante Pazzanese de Cardiologia | Not yet recruiting |
| Sao Paolo, Brazil | |
| Contact: Jose Carlos Pachon Mateos, MD 55-11-50510461 jcpachon@hotmail.com | |
| Principal Investigator: Jose Carlos Pachon Mateos, MD | |
| Colombia | |
| 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 |
| Principal Investigator: | 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: | October 3, 2012 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Brazil: National Health Surveillance Agency 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:
|
Heart Diseases Chagas Disease Cardiovascular Diseases Trypanosomiasis |
Euglenozoa Infections Protozoan Infections Parasitic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013