Heart Failure
Conditions
Keywords
Occlutech AFR, Atrial Flow Regulator, Interatrial shunt device, Heart failure, HFrEF, HFpEF, Left-to-right shunt, Balloon atrial septostomy, MACNE, Device embolization, AFR, AFR Registry
Brief summary
This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.
Detailed description
This is a prospective, multicentre, international, follow-up registry to monitor the safety and the performance of the Occlutech AFR device in patients with Heart Failure, to identify unknown side effects and to assess the indications and contraindications for an AFR treatment. Efficacy and safety of implanted device(s) will be evaluated by vital signs, laboratory test, quality of life questionnaire, ECG, and echocardiography data over a follow-up period of 36 month after implantation. Patients will be treated according to the instruction-for-use of the device and according to clinical routine. Procedures will be performed at sites having appropriate laboratory support and adequately trained imaging personnel. Procedures will be performed by physicians with experience in a wide range of interventional cardiology and structural heart disease.
Interventions
DEVICEOcclutech Atrial Flow Regulator
The Occlutech Atrial Flow Regulator is an interatrial shunt device for transcatheter delivery.
Sponsors
Occlutech International AB
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of subjects with at least one SAE/ (S)ADE at 12 months, 24 months and 36 months after implantation. | 3 years | — |
| Cardiovascular Events at 12 months, 24 months and 36 months after implantation. | 3 years | Heart Failure hospitalization rate; Cardiovascular mortality; Unplanned HF admission or treatment intensification. |
| Device performance at 12 months, 24 months and 36 months after implantation. | 3 years | Device placed in situ as assessed by the investigator; Patency: evidence of LEFT TO RIGHT shunt through the AFR device; Implant embolization and clinically significant device migration. |
| NYHA class status in comparison to Baseline. | 3 years | — |
| Subject QoL assessment using the KCCQ in comparison to Baseline. | 3 years | — |
| 6 Minute Walk Test distance [m] in comparison to Baseline. | 3 years | — |
| Heart rhythm in comparison to Baseline | 3 years | — |
| Left Ventricular (LV), Right Ventricular (RV) and Left Atrial (LA) structure and function including strain derived indices in comparison to Baseline. | 3 years | — |
| Left Ventricular Ejection Fraction (LVEF) in comparison to Baseline. | 3 years | — |
| Tricuspid Annular Plane Systolic Excursion (TAPSE) in comparison to Baseline. | 3 years | — |
| Laboratory variables | 3 years | Laboratory variables, including changes from baseline in: eGRF, NT-Pro-BNP \[pg/ml\] |
| Changes in heart failure related medication | 3 years | reduction/increase of daily dose \[%\] |
| Relationship between pacemaker therapy and intra atrial shunt therapy | 3 years | — |
Countries
France, Germany, Greece, Italy, Portugal, Serbia, Tunisia, Turkey (Türkiye)
Contacts
CONTACTGönül Sonmez Utkun
CONTACTSankoung Minte
Outcome results
None listed