Follows people with heart failure who received an atrial flow regulator device

Trial details

Who runs it

Occlutech International AB

Trial code

NCT04405583

Record updated

8 June 2026

Original description

This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.Read full original descriptionShow less

A Multicentre, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech Atrial Flow Regulator in Heart Failure Patients

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

Inclusion: Written, informed consent; Age ≥18 years; Presence of chronic symptomatic HF (NYHA class ≥ 2); Left Atrial Pressure (LAP) > Right Atrial Pressure (RAP); with a gradient equal or more than 5 mmHg*; 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); Stable guideline directed treatment according to latest applicable ESC guidelines for respective HF phenotypes for at least 1 months prior to informed consent.

Exclusion: Previous interventional or surgical atrial septal defect (ASD) or patent foramen ovale (PFO) closure interfering with the placement of the device; Prior diagnosis of primary pulmonary hypertension; 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; 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; Patients with sepsis (local or generalized) or other acute infection(s) requiring systemic antibiotics in the two months prior enrollment; 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; Evidence of right heart failure defined (by ECHO) as:; Severe Right Ventricular Dysfunction (TAPSE < 14 mm); Severe Right Ventricular Dilatation (RV volume ≥ LV volume); Severe pulmonary hypertension (PASP > 60 mm Hg); Uncontrolled hypertension, Systolic Blood Pressure of >160 mmHg or Diastolic Blood Pressure ≥ 100mmHg, despite medical therapy at the time of screening visit; Uncontrolled atrial fibrillation with resting heart rate >110bpm, despite medical therapy; Documented history of specific cardiomyopathy (obstructive hypertrophic, restrictive, infiltrative) or pericardial disease; Congenital heart defect that interferes with placement of the device, at the discretion of the Investigator; Clinically significant valvular heart disease:; regurgitation grade ≥3+ or; severe stenosis of mitral or tricuspid valves, or; significant stenosis of aortic valves; Severe Chronic Obstructive Pulmonary Disease (COPD) requiring oral steroid therapy or oxygen administration; Clinically significant coagulation disorder, at discretion of investigator; Chronic kidney disease currently requiring dialysis; Allergy to nickel and/or titanium and/or nickel/titanium-based materials, if not medically manageable; 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); Allergy to anti-platelet, anti-coagulant or anti-thrombotic therapy; Echocardiographic evidence of intra-cardia mass, thrombus or vegetation; 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; ICD or right sided pacemaker placement within 2 months; Participating in another investigational clinical trial that could interfere with this study, at the discretion of the investigator.

ClinicalTrials.gov NCT04405583