Status:
UNKNOWN
Atrial Flow Regulator in Heart Failure
Lead Sponsor:
Szpitale Pomorskie Sp. z o. o.
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the study is to assess invasive and non-invasive parameters that may predict clinical improvement in patients with congestive heart failure after implantation of Occlutech® Atrial flow regu...
Eligibility Criteria
Inclusion
- 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:
- Pulmonary artery wedge pressure (PAWP) at rest \> 15 mmHg or
- PAWP \> 25 mmHg during hand grip test
Exclusion
- 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:
- Right atrial pressure ≥ PAWP (measured in right heart catheterization)
- 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
Key Trial Info
Start Date :
January 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04334694
Start Date
January 7 2020
End Date
January 1 2022
Last Update
April 6 2020
Active Locations (1)
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1
Kashubian Cardiovascular Center
Wejherowo, Poland, 84-200