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Clinical Trials in Germany / NCT04405583
Recruiting Observational

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

NCT04405583 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2020-10-28
Last updated
2026-06-08

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Occlutech Atrial Flow Regulator

Occlutech Atrial Flow Regulator: The Occlutech Atrial Flow Regulator is an interatrial shunt device for transcatheter delivery.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
CHU Besançon Besançon France Recruiting
CHU Bourdeaux Bourdeaux France Recruiting
CHU Lyon Lyon France Recruiting
CHU Montpellier Montpellier France Recruiting
Centre Hospitalier Universitaire Rangueil Toulouse France Not Yet Recruiting
Knappschaftskrankenhaus Bottrop GmbH Bottrop Germany Not Yet Recruiting
Clinic Coburg Coburg Germany Recruiting
University Clinic Cologne Germany Recruiting
Helios Clinic Erfurt Erfurt Germany Active Not Recruiting
Cardiologicum Hamburg Hamburg Germany Terminated
WKK Heide Heide Germany Recruiting
University Clinic Jena Jena Germany Recruiting
Hospital Osnabrueck Osnabrück Germany Recruiting
Elbe Clinic Stade Stade Germany Recruiting
University Clinic Tübingen Tübingen Germany Active Not Recruiting
Hippokration Hospital Athens Athens Greece Recruiting
Mitera Hospital Athens Athens Greece Not Yet Recruiting
Onassis Cardiac Surgery Center Athens Greece Not Yet Recruiting
European Interbalkan Medical Center Thessaloniki Greece Recruiting
Hippokration Hospital of Thessaloniki Thessaloniki Greece Recruiting
Careggi University Hospital Florence Italy Not Yet Recruiting
Centro Cardiologico Monzino Milan Italy Recruiting
Hospital de Santa Cruz Carnaxide Portugal Not Yet Recruiting
Hospital de Santa Marta Lisbon Portugal Not Yet Recruiting
Dedinje Cardiovascular Institute Dedinje Serbia Not Yet Recruiting
Rabta Hospital Tunis Tunisia Recruiting
The Military Hospital of Tunis Tunis Tunisia Recruiting
Ankara Etlik Şehir Hastanesi Ankara Turkey (Türkiye) Recruiting
Güven Hospital Ankara Turkey (Türkiye) Recruiting
Hacettepe Üniversitesi Tip Fakültesi Ankara Turkey (Türkiye) Recruiting
Firat University Hospital Elâzığ Turkey (Türkiye) Recruiting
Binali Yildirim University Mengücek Gazi Training and Resear Erzincan Turkey (Türkiye) Recruiting
Bezmialem Uni. Hospital Fatih Turkey (Türkiye) Recruiting
İzmir City Hospital Izmir Turkey (Türkiye) Recruiting
Kocaeli Üniversitesi Araştirma Ve Uygulama Hastanesi Kocaeli Turkey (Türkiye) Recruiting
Namik Kemal University Hospital Tekirdağ Turkey (Türkiye) Recruiting

More Occlutech International AB trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04405583 on ClinicalTrials.gov ↗ ← All trials in Germany