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The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients

Recruitingn/aAges 18 Years - anyAllOcclutech International AB
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In plain words

What the trial is, and whether it could suit you

This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Written, informed consent 2. Age ≥18 years 3. Presence of chronic symptomatic HF (NYHA class ≥ 2) 4. Left Atrial Pressure (LAP) \> Right Atrial Pressure (RAP); with a gradient equal or more than 5 mmHg\* 5. LVEF ≥ 15%. If LVEF is \>40% (HFpEF), BMI corrected\*\* NT-pro-BNP must be elevated ≥ 125 pg/mL. (BNP \>35 pg/mL) or ≥ 365pg/ml (BNP \> 105 pg/mL) for patients with atrial fibrillation (AF) 6. Stable guideline directed treatment according to latest applicable ESC guidelines for respective HF phenotypes for at least 1 months prior to informed consent Exclusion Criteria: 1. Life expectancy \< 1 year, or advanced heart failure defined as ACC/AHA Stage D heart failure, or listed for heart transplantation at time of baseline visit 2. Evidence of right heart failure defined (by ECHO) as: 1. Severe Right Ventricular Dysfunction (TAPSE \< 14 mm) 2. Severe Right Ventricular Dilatation (RV volume ≥ LV volume) 3. Severe pulmonary hypertension (PASP \> 60 mm Hg) 3. Echocardiographic evidence of intra-cardia mass, thrombus or vegetation 4. Uncontrolled hypertension, Systolic Blood Pressure of \>160 mmHg or Diastolic Blood Pressure ≥ 100mmHg, despite medical therapy at the time of screening visit. 5. Uncontrolled atrial fibrillation with resting heart rate \>110bpm, despite medical therapy 6. Documented history of specific cardiomyopathy (obstructive hypertrophic, restrictive, infiltrative) or pericardial disease 7. Congenital heart defect that interferes with placement of the device, at the discretion of the Investigator. 8. Previous interventional or surgical atrial septal defect (ASD) or patent foramen ovale (PFO) closure interfering with the placement of the device 9. Current atrial septal defect, or anatomical anomaly (including \> 10 mm atrial septal thickness or atrial septal aneurysm) on ECHO that precludes implantation of the device across the fossa ovalis (FO) of the interatrial septum 10. Clinically significant valvular heart disease: 1. regurgitation grade ≥3+ or 2. severe stenosis of mitral or tricuspid valves, or 3. significant stenosis of aortic valves 11. Prior diagnosis of primary pulmonary hypertension 12. Severe Chronic Obstructive Pulmonary Disease (COPD) requiring oral steroid therapy or oxygen administration 13. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within 6 months, or any prior stroke with persistent neurologic deficit, or any prior intracranial bleed, or known intracerebral aneurysm, AV malformation or other intracranial pathology increasing the risk of bleeding 14. Myocardial Infarction (MI) and/or coronary heart disease with indication for a coronary intervention or Coronary Artery Bypass Grafting (CABG) or within 2 months prior to informed consent. 15. ICD or right sided pacemaker placement within 2 months 16. Clinically significant coagulation disorder, at discretion of investigator 17. Patients with sepsis (local or generalized) or other acute infection(s) requiring systemic antibiotics in the two months prior enrollment 18. Chronic kidney disease currently requiring dialysis 19. Allergy to nickel and/or titanium and/or nickel/titanium-based materials, if not medically manageable 20. Allergy to anti-platelet, anti-coagulant or anti-thrombotic therapy 21. Participating in another investigational clinical trial that could interfere with this study, at the discretion of the investigator 22. Other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator Note: \* LA pressure is substituted by PCW at the right heart catheterization measure while patient is awaken \*\*"Corrected" refers to a 4% reduction in the NT-proBNP cutoff for every increase of 1kg/m2 in body mass index (BMI) above a reference BMI of 20kg/m2)
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What it tests

  • Occlutech Atrial Flow Regulator
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Where

36 sites
CHU Besançon
Besançon, France
CHU Bourdeaux
Bourdeaux, France
CHU Lyon
Lyon, France
CHU Montpellier
Montpellier, France
Centre Hospitalier Universitaire Rangueil
Toulouse, France
Knappschaftskrankenhaus Bottrop GmbH
Bottrop, Germany
Clinic Coburg
Coburg, Germany
University Clinic
Cologne, Germany

…and 28 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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