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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT01715558
Eligibility Criteria:
Inclusion Criteria:
1. Patients implanted with any of BSC dual chamber PM devices equipped with RHYTMIQ with the algorithm programed to ON based on clinical indication at the time of discharge from the hospital
2. Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center
3. Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law
Exclusion Criteria:
1. Patients with 3rd degree AV block
2. Patients with permanent AF
3. Patients followed up remotely with remote patient management system.
4. Patients who are unable to be followed up by the participating centers for a period of two years
5. Patients who have a current device implanted for more than 15 days
6. Women of childbearing potential who are pregnant, or plan to become pregnant during the time of the study (method of assessment upon physician's discretion)
7. Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry or extensions/amendments of the current protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01715558
Study Brief:
Protocol Section:
NCT01715558