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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT03992560
Eligibility Criteria:
Inclusion Criteria:
* \>18yrs of age
* Standard indication for CRT-P or CRT-D according to European Society of Cardiology (ESC)/European Heart Rhythm (EHRA) guidelines.1
* Stable on optimal medical therapy for at least 3 months
* Ischaemic aetiology
* Patients with atrial fibrillation can be included
Exclusion Criteria:
* Any contraindication to pacing /implantable cardioverter-defibrillator (ICD) implant
* Requirement for endocardial pacing
* Contraindication to gadolinium contrast enhanced cardiac Magnetic Resonance (MR) scanning
* Significant claustrophobia
* Significant renal impairment with estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2
* Existing pacemaker or ICD system or extraction of a CRT system within the last 6 months
* Participation in other studies with active treatment/ investigational arm
* Pregnant or planning to become pregnant in the next 7 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03992560
Study Brief:
Protocol Section:
NCT03992560