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Monitoring the Occlutech AFR device in heart failure patients

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

Observational Occlutech International AB · NCT04405583

This study is testing how safe and effective the Occlutech AFR device is for people with heart failure over three years.

Quick facts

Study typeObservational
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorOcclutech International AB Industry-sponsored
Locations36 sites (Besançon and 35 other locations)
Trial IDNCT04405583 on ClinicalTrials.gov

What this trial studies

This observational study is a prospective, multicentre, international registry designed to monitor the safety and efficacy of the Occlutech Atrial Flow Regulator (AFR) device in patients suffering from heart failure. Over a follow-up period of 36 months, the study will evaluate the device's performance through various assessments including vital signs, laboratory tests, quality of life questionnaires, ECG, and echocardiography. Patients will be treated according to the device's instructions and clinical routine, with procedures conducted by experienced interventional cardiologists at well-equipped sites.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with chronic symptomatic heart failure classified as NYHA class 2 or higher.

Not a fit: Patients with advanced heart failure or those with a life expectancy of less than one year are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of the Occlutech AFR device, potentially improving treatment options for heart failure patients.

How similar studies have performed: While this study focuses on a specific device, similar observational studies have shown promise in monitoring heart failure treatments, suggesting a potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Besançon and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart FailureOcclutech AFRAtrial Flow RegulatorInteratrial shunt deviceHeart failureHFrEFHFpEFLeft-to-right shunt
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.