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:
NCT01523704
Eligibility Criteria:
Inclusion Criteria:
* Indicated for IPG implantation under Japanese guidelines
* Implanted within the last 45 days or being considered for implant with a BIOTRONIK IPG with Home Monitoring
* Able to utilize HM system throughout the study
* Ability to give informed consent
* Geographically stable and able to return for follow-ups for 27 months
* Over 20 years old
* Patient able to understand and follow the procedure stated in protocol
Exclusion Criteria:
* Contraindicated for IPG under Japanese guidelines
* Patients who are currently included in another cardiac clinical study
* Patients with expected life period of less than two years
* Patients who might undergo heart transplantation in next two years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01523704
Study Brief:
Protocol Section:
NCT01523704