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 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT05951166
Eligibility Criteria:
Inclusion Criteria:
* Heart Failure with EF ≥ 40% (by TTE within last 3 months)
* Mean Pulmonary Artery Pressure (mPAP) \>20 mmHg at rest
* Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest
* Pulmonary Capillary Wedge Pressure \> 15 mmHg (at rest) or \> 18 with passive leg raise
* Cardiac index (CI) ≥ 1.7 L/min/m2
* NYHA Class II or III
* Glomerular Filtration Rate (GFR) ≥ 25 ml/min
* N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥ 400pg/mL
* Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment
Exclusion Criteria:
* Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
* Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device
* Systemic infection or localized infection/rash at planned access site at time of procedure
* Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 3 months
* CRT or other Interventional cardiac procedure (except RHC) within last 3 months
* Any planned cardiac procedure or inpatient procedure within the next 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
85 Years
Study:
NCT05951166
Study Brief:
Protocol Section:
NCT05951166