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:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT06065800
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients.
* Age ≥ 18 years.
* Scheduled sternotomy within the next 3 days.
* Use of STEELEX® Sternum Set + Bone Wax® for sternotomy following routine clinical practice
* Use of STEELEX® Electrode Set in temporary epicardial cardiac pacing during the postoperative phase of open-heart surgery in combination with an external pacemaker following routine clinical practice.
* Written Informed Consent form.
Exclusion Criteria:
* Participation or planned participation in any clinical trial before study follow-up is completed.
* Pregnancy and/or breastfeeding.
* Patient undergoing emergency surgery.
* Patients taking medical consumption that might affect sternal healing (based on investigator's own clinical criteria)
* Patient with any hypersensitivity or allergy to the components of the medical device.
* Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to comply with the study procedures.
* Use of STEELEX® Electrode Set in permanent cardiac pacing or for permanent monitoring.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06065800
Study Brief:
Protocol Section:
NCT06065800