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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT05731466
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent obtained from subject
2. \> 18 years of age
3. Diagnosis of NYHA Class III Heart Failure with preserved ejection fraction defined as LVEF≥45%
4. At least 1 heart failure related hospitalization or urgent outpatient visit within 12 months of baseline visit
5. Presence of pulmonary hypertension defined as mPAP\>25 mmHg at rest or mPAP/CO slope \>3 mmHg/L/min during exercise during right heart catheterization or tricuspid regurgitation velocity of \> 2.8 m/s assessed by transthoracic echocardiography (data must be taken within the last 6 months prior to implantation)
6. Subjects with a BMI ≤ 35. Subjects with BMI \>35 will require their chest circumference to be measured at the axillary level, if \> 65 inches the patient will not be eligible for the study.
7. Subjects with pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the RHC)
8. Subjects willing and able to comply with the follow-up requirements of the study
9. All participants need to be able to perform at least 40 watts on an upright bicycle stress test.
Exclusion Criteria:
1. Subjects with an active infection
2. Subjects with history of recurrent (\> 1) pulmonary embolism or deep vein thrombosis
3. Subjects who, in the Investigator's opinion, are unable to tolerate a right heart catheterization
4. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within 2 months of Baseline Visit
5. Subjects with Cardiac Resynchronization Device (CRT) , pacemaker or Implantable Cardioverter Defibrillator (ICD)
6. Subjects with a Glomerular Filtration Rate (GFR) \< 25 ml/min (obtained within 2 weeks of the baseline visit) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
7. Subjects with congenital heart disease or mechanical heart valve(s)
8. Subjects likely to undergo heart transplantation or VAD within 6 months of baseline visit
9. Subjects with known coagulation disorders
10. Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel (not applicable for subjects taking anti-coagulation therapy or other approved anti-platelets therapy).
11. Subjects with history of coronary artery bypass surgery (CABG)
12. Subjects with severe valvular disease (4/4)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05731466
Study Brief:
Protocol Section:
NCT05731466