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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01168518
Eligibility Criteria:
Inclusion Criteria:
* The implanted lead must allow the measurement of pacing threshold at 0.5ms, R-wave or P-wave amplitude and impedance of the lead.
* Included patients may receive more than one lead under evaluation.
Exclusion Criteria:
* Any contraindication to endocavitary lead implantation;
* Inability to understand the purpose of the study or refusal to co-operate.
* Geographically unstable or unavailability for scheduled M1-M3 follow-up at the implanting centre as defined in the investigational plan.
* Patient of minor age (\<18)
* Pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01168518
Study Brief:
Protocol Section:
NCT01168518