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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT01535404
Eligibility Criteria:
Inclusion Criteria:
* Requirement for ventricular pacing according to current guidelines (including chronic atrial fibrillation)
* Anticipated \>=50% daily ventricular pacing
* LVEF \>=45% as evaluated by 2D-echocardiography, 3D-echocardiography, magnetic resonance imaging or by radionuclide/contrast ventriculography
* Minimum age of 18 years, and at least 1 year life expectancy
Exclusion Criteria:
* Prior tricuspid valve replacement (annuloplasty is permitted)
* Intrinsic rhythm \< 30bpm
* Patients with permanent atrial fibrillation who undergo ablation of the atrioventricular node.
* Echocardiographic window of insufficient quality for measuring LVEF
* Life expectancy of \< 1year
* Pregnancy (women of childbearing potential will undergo pregnancy testing)
* Unable of unwilling to sign a patient informed consent form
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01535404
Study Brief:
Protocol Section:
NCT01535404