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 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT04657718
Eligibility Criteria:
Patients scheduled to undergo lead placement for cardiac pacing. Subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study.
Inclusion Criteria:
1. Subject must be aged \>18 years.
2. Subject must have signed a written iInformed Cconsent form to participate in the study, prior to any study related procedures.
3. Subject must be willing to comply with the protocol requirements.
4. Subject is scheduled for a de novo pacing lead implantation or system upgrade .
Exclusion Criteria:
1. Patients for whom previous CRT or conduction pacing implantation has failed.
2. Patients considered for leadless cardiac pacing system.
3. Patients undergoing a system revision for infection or malfunction.
4. Patients undergoing planned, urgent or emergency lead revision or lead extraction.
5. Subjects who have received or will receive an experimental drug or used an experimental medical device within 30 days before the planned start of treatment.
6. Patients included in a clinical registry or clinical trial for an investigational product.
7. Pregnant women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04657718
Study Brief:
Protocol Section:
NCT04657718