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 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT00311168
Eligibility Criteria:
Inclusion Criteria:
* Patient has been implanted with dual chamber SJM Victory® device with VIP™ for 1 month (± 2 weeks).
* At the time of pacemaker implant, VIP™ is programmed "OFF".
* At the time of enrollment, patient is paced in the RV ≤ 60% of the time.
* Patient is medically stable.
Exclusion Criteria:
* Patient has evidence of complete AV block, such that ventricular pacing would be required as part of the patient's routine management.
* Patient is indicated for AF Suppression.
* Patient has persistent or chronic atrial fibrillation.
* Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons.
* Patient is currently participating in another device research study.
* Patient is younger than 18 years of age.
* Patient is pregnant.
* Patients life expectancy is less than 12 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT00311168
Study Brief:
Protocol Section:
NCT00311168