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 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT01537718
Eligibility Criteria:
Inclusion Criteria: Any patient enrolled in the study must fulfil all of the following criteria:
* Patients eligible for implantation of a single or dual-chamber pacemaker according to current available guidelines
* Patients who are scheduled for implant of a REPLY 200 SR; or REPLY 200 DR pacemaker
* Patients who provide signed and dated informed consent
Exclusion Criteria:
* Inability to understand the purpose of the study or refusal to co-operate
* Unavailability for scheduled follow-ups at the implanting centre
* Already included in another clinical study that could affect the results of this study
* Inability or refusal to provide informed consent
* Patient is minor (less than 18-years old)
* Patient is pregnant (women of childbearing potential should have a negative pregnancy test prior to enrolment)
* Patient is forfeiture of freedom or under guardianship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01537718
Study Brief:
Protocol Section:
NCT01537718