Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-24 @ 12:15 PM
NCT ID:
NCT01539161
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01539161
Study Brief:
Protocol Section:
NCT01539161