Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-01-07
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Atrial flow regulator
In this arm, patients who have elevated left ventricle filling pressures get (Occlutech® AFR device) and optimal therapy for Heart failure (HF).
Atrial flow regulator (Occlutech® AFR device)
Atrial septostomy followed by implantation of AFR.
Interventions
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Atrial flow regulator (Occlutech® AFR device)
Atrial septostomy followed by implantation of AFR.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Szpitale Pomorskie Sp. z o. o.
OTHER
Responsible Party
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Principal Investigators
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Lukasz Lewicki, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Kashubian Cardiovascular Center; University Center for Cardiology
Locations
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Kashubian Cardiovascular Center
Wejherowo, , Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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01/2020/W
Identifier Type: -
Identifier Source: org_study_id
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