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)
Rate of subjects with at least one Major Adverse Cardiovascular and Neurologic Events (MACNE) in the 1 year following implantation. — 1 year MACNE includes all-cause mortality, stroke, systemic thromboembolism, open cardiac surgery or major endovascular repair, and major bleeding (BARC 3-5).
Trial sites (36)
Facility
City
Region
Status
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
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.
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