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:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT00246805
Eligibility Criteria:
Inclusion Criteria:
* Patient has signed informed consent form
* Patient with permanent atrial fibrillation, standard indication for VVI(R) pacing, and at least 1 episode of rate irregularity in the last month
* New York Heart Association (NYHA) Class I, II, III
* Patient is able to comply with follow-up times and will comply with the protocol
* \> 18 years of age
Exclusion Criteria:
* Paroxysmal atrial fibrillation
* NYHA Class IV
* Left ventricular ejection fraction (LVEF) \< 35
* Patients with unstable angina
* Patients who have experienced an acute myocardial infarction or received coronary artery revascularization (CABG), or coronary angioplasty (PTCA) within 3 months prior to enrolment
* Patient candidate for cardiac surgery, or coronary angioplasty (PTCA)
* Patients who experienced a cardiovascular accident (CVA) or transient ischemic attack (TIA) with permanent disability
* Life expectancy \< 12 months due to other medical conditions
* Pregnancy
* The patient is enrolled in any concurrent (drug and/or device) study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00246805
Study Brief:
Protocol Section:
NCT00246805