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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT00531661
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of HF ≥ 3 months, with either preserved or reduced LVEF
2. Diagnosis of NYHA Class III HF (historical assessment documented at screening visit)
3. Subjects with reduced LVEF must be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the subject is intolerant to beta blockers, ACE-I or ARB. Beta blockers and ACE-I (or ARB) doses should be stable for one month prior to study entry.
4. At least 1 HF hospitalization within 12 months of Screening Visit
5. Subjects with pulmonary artery branch diameter sized between 7mm and 15mm (implanted vessel)
Exclusion Criteria:
1. Subjects with history of recurrent (\> 1) pulmonary embolism or deep vein thrombosis
2. Subjects, in the Investigator's opinion, unable to tolerate a right heart catheterization
3. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of Screening Visit
4. Subjects with Cardiac Resynchronization Device (CRT) implanted ≤ 3 months prior to enrollment
5. Subjects with a Glomerular Filtration Rate (GFR) \<25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis
6. Subjects likely to undergo heart transplantation within 6 months of Screening Visit
7. Subjects with congenital heart disease or mechanical right heart valve(s)
8. Subjects with known coagulation disorders
9. Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00531661
Study Brief:
Protocol Section:
NCT00531661