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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT04269733
Eligibility Criteria:
Inclusion Criteria:
* Male or female ≥ 18 years
* De novo DDD PM implanted at Aalborg University Hospital
* PM implantation due to advanced AV block
* Duration of pacemaker treatment ≥ 1 year at time of screening
* Normal LVEF (≥50%) prior to PM implantation
* Actively attending follow-up at the PM outpatient clinic at Aalborg University Hospital after PM implantation
Exclusion Criteria:
* No written informed consent
* Baseline TTE not available or insufficient quality for assessment of LVEF
* Contraindications to a new contrast CT if no previous contrast-enhanced cardiac CT, showing RV lead position, is available
* RV pacing load \< 40%.
* Deceased
* Not attending follow-up at the PM outpatient clinic at Aalborg University Hospital after PM implantation
* Device complications with removal of original implanted pacing lead \> 3 months after primary implantation
* Subjects with severe ischemic heart disease and severe valvular heart disease.
* Terminal illness or unable to provide informed consent at time of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04269733
Study Brief:
Protocol Section:
NCT04269733