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:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT06843135
Eligibility Criteria:
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Age ≥ 18 years
* Patients with a left ventricular ejection fraction of ≥35%
* Patients with an indication for ventricular pacing and high-degree atrioventricular block where the degree of anticipated RV pacing is \>20% including:
* Third degree AV block
* Symptomatic or asymptomatic second-degree AV block
* High degree AV block
* Pace and ablate (AV-node ablation)
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* CRT indication (patients with heart failure (NYHA \>1) in sinus rhythm with left ventricular ejection fraction (LVEF) \<35%, QRS duration \>150 ms, and left bundle branch block (LBBB) QRS morphology despite optimised medical therapy)
* Inability to undergo CMR (i.e. severe claustrophobia or MRI contraindications)
* Life expectancy \<12 months
* Indication for an implantable cardioverter defibrillator
* Presence of severe valve disease or mechanical valves
* Any prior attempt at implantation of an ICD, CRT, CSP
* Permanent AF with rapid ventricular response, unless pace and ablate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06843135
Study Brief:
Protocol Section:
NCT06843135