Atrial Flow Regulator in Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Pomeranian atRial flOw reguLatOr iN conGestive hEart failuRe (PROLONGER) Trial

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Device: Atrial flow regulator (Occlutech® AFR device)


Participation Criteria
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Eligibility Criteria
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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: Pulmonary artery wedge pressure (PAWP) at rest > 15 mmHg or 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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All eligible patients will undergo detailed screening using echocardiography, impedance cardiography and right heart catheterization prior to AFR implantation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Atrial flow regulator<br>In this arm, patients who have elevated left ventricle filling pressures get (Occlutech® AFR device) and optimal therapy for Heart failure (HF). | Device: Atrial flow regulator (Occlutech® AFR device)<br>* Atrial septostomy followed by implantation of AFR.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement | Increase in 6 minutes walk test distance | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial flow regulator; heart failure; interatrial shunting