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 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT06620705
Eligibility Criteria:
INCLUSION CRITERIA
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Adults ≥18 years with permanent AF and LVEF \< 50% who either require ventricular pacing because of bradycardia including patients undergoing AV junction ablation, or have an indication for cardiac resynchronization therapy.
* Expected percentage of ventricular pacing \> 40%
* ≥ 3 months of heart failure medication optimization
Of note, patients who already have a device, but require an upgrade to a CRT device, can also be included
EXCLUSION CRITERIA
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Age \< 18 years
* Pregnancy or active pregnancy wish
* Not eligible for implantation of an RV lead, LBBAP lead, or LV lead in the coronary sinus
* Recent valve intervention/surgery or acute myocardial infarction (\< 6 months)
* NYHA functional class IV heart failure, left ventricular assist device or cardiac transplant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06620705
Study Brief:
Protocol Section:
NCT06620705