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:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT04334694
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Symptomatic heart failure (HF) in NYHA class III or IV ambulatory
* Optimal medical therapy of HF according to European Society of Cardiology (ESC) guidelines for last 6 months
* Hospitalization because of HF decompensation in last 12 months
* Absence of significant valvular disease requiring cardiac surgery
* Life expectancy ≥ 1 year
* Written informed consent obtained from the patient
* Left ventricle ejection fraction (LVEF) ≥ 15%
* Elevated left heart filling pressures:
1. Pulmonary artery wedge pressure (PAWP) at rest \> 15 mmHg or
2. PAWP \> 25 mmHg during hand grip test
Exclusion Criteria:
* Participation in another clinical trial in last 30 days
* Acute infection or sepsis
* Severe coagulation disorder
* Allergy to nickel or titanium
* Severe peripheral artery disease disabling 6 minutes walk test
* Allergy to antiplatelet drugs, oral anticoagulants or heparin
* Contraindication to trans-oesophageal echocardiography (TEE)
* Pregnancy
* Atrial septal defect (ASD) or presence of atrial septal occluder
* Severe patent foramen ovale (PFO) with significant left to right shunt in rest
* Intracardiac thrombus
* Acute coronary syndrome or Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) in last 6 months
* Severe pulmonary hypertension:
1. Right atrial pressure ≥ PAWP (measured in right heart catheterization)
2. Right atrial pressure \> 20 mmHg (measured in right heart catheterization)
* Planned heart transplantation
* Transient ischemic attack or stroke within last 6 months
* Cardiac resynchronisation therapy (CRT) within last 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04334694
Study Brief:
Protocol Section:
NCT04334694