Clinical Trials in Italy / 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 Italy tracker
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
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 | Kocaeli | Turkey (Türkiye) | Recruiting |
| Namik Kemal University Hospital | Tekirdağ | Turkey (Türkiye) | Recruiting |
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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 Italy