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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT00422669
Eligibility Criteria:
Inclusion Criteria:
* Subjects that are expected to be paced in the right ventricle (RV) greater than 90 percent of the time
* Subjects with an ejection fraction of greater than 40 percent within 3 months prior to enrollment
* Subjects greater than 18 yrs of age
* Subjects that are indicated for a dual chamber pacemaker
* Subjects that will be implanted with a market released dual chamber Medtronic pacemaker and 3830 SelectSecure Lead in the ventricle
Exclusion Criteria:
* Subjects indicated for cardiac resynchronization therapy (CRT) device (based on American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines)
* Subjects indicated for an implantable cardiac defibrillator (ICD)
* Subjects with permanent atrial fibrillation (AF)
* Subjects with expected managed ventricular pacing turned on
* Subjects with a previously implanted pacemaker, ICD, or CRT device
* Subjects with an myocardial infarction (MI) within 3 months prior to enrollment
* Subjects that received bypass surgery within 3 months prior to enrollment
* Subjects that had valve replacement within 3 months prior to enrollment
* Subjects where a RV lead cannot be placed, (i.e., complex congenital heart disease
* Subjects with a mechanical right heart valve
* Women who are pregnant or nursing
* Significant co-morbidity preventing study completion
* Terminal conditions with a life expectancy of less than two years
* Participation in another study that would confound the results of this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00422669
Study Brief:
Protocol Section:
NCT00422669