The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients
NCT ID: NCT04405583
Last Updated: 2024-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2020-10-28
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Occlutech Atrial Flow Regulator
The Occlutech Atrial Flow Regulator is an interatrial shunt device for transcatheter delivery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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Occlutech International AB
INDUSTRY
Responsible Party
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Locations
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CHU Besançon
Besançon, , France
CHU Lyon
Lyon, , France
CHU Montpellier
Montpellier, , France
Knappschaftskrankenhaus Bottrop GmbH
Bottrop, , Germany
Clinic Coburg
Coburg, , Germany
University Clinic
Cologne, , Germany
Helios Clinic Erfurt
Erfurt, , Germany
Cardiologicum Hamburg
Hamburg, , Germany
WKK Heide
Heide, , Germany
University Clinic Jena
Jena, , Germany
Clinic Osnabrück
Osnabrück, , Germany
Hospital Osnabrueck
Osnabrück, , Germany
Elbe Clinic Stade
Stade, , Germany
University Clinic Tübingen
Tübingen, , Germany
Countries
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Central Contacts
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Other Identifiers
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Occ2020_01
Identifier Type: -
Identifier Source: org_study_id
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