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 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT05632432
Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained
* Left ventricular ejection fraction (LVEF) between ≥ 15% and ≤ 40% at recruitment (transthoracic echocardiography)
* New York Heart Association (NYHA) Class II-IV heart failure symptoms
Exclusion Criteria:
* Heart failure due to left ventricular outflow tract obstruction
* Acute myocardial infarction (AMI) within last 30 days
* History of life-threatening and possibly repeating ventricular arrhythmias or resuscitation, or an implantable cardioverter-defibrillator
* Stroke or other disabling condition within 3 months before screening
* Severe valve disease or scheduled valve surgery
* Renal dysfunction (GFR \<45 ml/min/1.73m2)
* Other disease limiting life expectancy
* Contraindications for coronary angiogram or LGE-CMRI
* Participation in some other clinical trial
Screening Failure:
* After optimization of medications, no visible scar or LVEF ≥ 50% in preoperative LGE-CMRI
* Preoperative LGE-CMRI has not been performed prior scheduled CABG
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05632432
Study Brief:
Protocol Section:
NCT05632432