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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT02543632
Eligibility Criteria:
Inclusion Criteria:
* Post MI structural heart dysfunction represented by left ventricular (LV) wall motion abnormality (WMA)
* Symptomatic Heart Failure with reduced Ejection Fraction (EF) (≤ 40%)
* Receiving stable medication for heart failure according to the European Society of Cardiology (ESC) Heart Failure (HF) Guidelines
* \>18 years of age
* Provide written informed consent
* Agree to the protocol-required follow-up
Exclusion Criteria:
* Acute myocardial infarction (MI) of the left anterior descending territory within 90 days of enrollment or patients with suspected evolving MI at time of enrollment
* Cardiogenic shock within 72 hours of enrollment
* A known hypersensitivity or contraindication to aspirin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre medicated
* Other hemodynamically structural heart interventions or heart failure device treatment at time of Parachute implant, e.g. mitral valve clip or cardiac resynchronization therapy).
* Co-morbidities associated with a life expectancy of less than 12-months
* Treatment Arm only (Control Arm excluded from this criteria): Anatomical characteristics not suitable for treatment with the Parachute Implant device as screened by magnetic resonance imaging (MRI) or computerized tomography (CT). (Characteristics include inappropriate size and shape of the left ventricle, pseudo chordae or trabeculations interfering with device placement.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02543632
Study Brief:
Protocol Section:
NCT02543632