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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT01831518
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years old
* Fulfils established clinical criteria for CRT implantation (with or without a defibrillator)
* NYHA Class III-IV Heart Failure (or NYHA II with NYHA III/IV symptoms in the preceding 12 months)
* LVEF \<35% (Calculated using echocardiography or Cardiac MR) at the time of implantation
* QRS duration \> 130ms
* Optimal Tolerated Medical Therapy for Heart Failure
Exclusion Criteria:
* Severe, life threatening non cardiac disease
* Active malignant disease and recent (\<5 years) malignant disease
* Prior Heart Transplant
* Recent history of unstable angina, acute coronary syndrome or myocardial infarction within three months of enrolment into the study
* Pregnancy
* Failure to participate in consent process
* Atrial Fibrillation
* Conventional pacemaker in situ
* Heart Failure requiring constant intravenous therapy including diuretics and/or inotropes
* Recent revascularisation procedure i.e. coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the last three months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01831518
Study Brief:
Protocol Section:
NCT01831518