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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 regulator (AFR) device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial flow regulator | Other | In this arm, patients who have elevated left ventricle filling pressures get (Occlutech® AFR device) and optimal therapy for Heart failure (HF). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atrial flow regulator (Occlutech® AFR device) | Device | Atrial septostomy followed by implantation of AFR. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement | Increase in 6 minutes walk test distance | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement II | Reduction in New York Heart Association (NYHA) class | 12 months |
| Device related adverse event | Device migration, embolization, device related thrombus, shunt occlusion, need for device removal |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary artery wedge pressure (PAWP) at rest | Reduction of PAWP at rest | 30 days after AFR |
| Pulmonary artery wedge pressure (PAWP) during handgrip test | Reduction of PAWP during handgrip test |
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:
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:
Planned heart transplantation
Transient ischemic attack or stroke within last 6 months
Cardiac resynchronisation therapy (CRT) within last 6 months
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lukasz Lewicki, MD, PhD | Contact | +48501702885 | luklewicki@gmail.com | |
| Maciej Karwowski, MD | Contact | +48500473983 | maciejkarwowskimd@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lukasz Lewicki, MD,PhD | Kashubian Cardiovascular Center; University Center for Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kashubian Cardiovascular Center | Recruiting | Wejherowo | 84-200 | Poland |
The following data will be available:
The data will be available after completion of the study.
The data will be shared on personal request for review process.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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All eligible patients will undergo detailed screening using echocardiography, impedance cardiography and right heart catheterization prior to AFR implantation.
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| 12 months |
| 30 days after AFR |
| KCCQ-12 | Kansas City Cardiomyopathy Questionnaire (KCCQ-12) | 12 months |
| Clinical adverse event | Cardiac mortality | 12 months |
| Clinical adverse event II | Rehospitalization for HF decompensation | 12 months |