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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT04225520
Eligibility Criteria:
(- - - - - - - - - Inclusion Criteria - - - - - - - - -)
The proposed inclusion criteria represent the minimum recommendations for CRT implantation in heart failure patients according to the ESC 2021 guidelines. In addition:
* Patient has a LVEF ≤ 35%
* Patient has a LVEDD ≥ 2.7cm/m² or LVEDD ≥ 50mm (m) and ≥45mm (f)
* Patient has been in a stable medical condition for ≥ 1 month prior inclusion
* Patient underwent complete revascularization in case of ischemia
* Patients is able to understand and willing to provide a written informed consent
* Patient is 18 years or older
(- - - - - - - - - Exclusion Criteria - - - - - - - - -)
Patients with the following conditions will be excluded:
* unreliable left ventricular volume measurements
* severe MR or more than moderate other valvular disease
* pulmonary hypertension, other than secondary to left heart disease
* patient on hemodialysis
* life expectancy \< 1 year
* pregnant or breastfeeding
Patients with prior right ventricular pacing between 20% to 80% will be excluded.
Patients with prior right ventricular pacing ≤ 20% or no pacemaker / ICD will be excluded if they have any of the following criteria:
* PR duration \> 250ms
* second / third degree atrioventricular block
* intrinsic QRS duration \< 130ms
* atrial fibrillation with resting HR \< 50/min or \> 80/min
Patients with prior right ventricular pacing ≥ 80% will be excluded if they have any of the following criteria:
* sensed AV delay \> 250ms
* paced AV delay \> 280ms
Patients with a prior pacemaker / ICD scheduled for LBBaP will be excluded regardless of pacing percentage
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04225520
Study Brief:
Protocol Section:
NCT04225520