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 @ 12:43 PM
Ignite Modification Date:
2025-12-24 @ 12:43 PM
NCT ID:
NCT01233661
Eligibility Criteria:
Inclusion Criteria:
* Chronically (i.e. implanted for at least six months) dual-chamber pacemaker
* Stable cardiac status (i.e. no hospitalizations or cardiac medication changes within 3 months)
* Ability to provide informed consent
Exclusion Criteria:
* Age \<18 years or \>80 years
* Pregnancy (if pregnancy is suspected, a urine pregnancy test will be performed)
* Recent (within 12 months) left ventricular ejection fraction \<50%
* Significant valvular heart disease (mitral regurgitation of greater than mild severity, any degree of mitral stenosis, aortic stenosis or insufficiency of greater than mild severity)
* Prior coronary artery bypass graft or valve surgery, recent (i.e. within 3 months) acute coronary syndrome or percutaneous coronary intervention, or chronic stable angina
* History of clinically important atrial or ventricular tachyarrhythmias, defined as complex ventricular ectopy (i.e. couplets, triplets, or ventricular tachycardia), AF, atrial tachycardia, or other supraventricular tachycardias not cured with prior ablative therapy).
* Significant chronic systemic inflammatory or neoplastic disease
* Chronic renal or hepatic insufficiency. Renal insufficiency will be defined as a creatinine clearance of less than 20 cc/min. Evidence of hepatic insufficiency will consist of abnormal synthetic function (INR \>1.4 without oral anticoagulant use, albumin \< 3.0 mg/dL) or abnormal clearance function (total bilirubin \>2.0).
* Uncorrected thyroid abnormalities
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01233661
Study Brief:
Protocol Section:
NCT01233661