The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT04405583
• Lead Sponsor: Occlutech International AB

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.

Study Timeline

• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-25
• Study First Posted: 2020-05-28
• Study Start: 2020-10-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-17
• Primary Completion: 2025-06-30
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Subject QoL assessment using the KCCQ 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 \[pg/ml\]
NYHA class status in comparison to Baseline.	3 years
Left Ventricular Ejection Fraction (LVEF) 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
Rate of subjects with at least one SAE/ (S)ADE at 12 months, 24 months and 36 months after implantation.	3 years
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.
Heart rhythm in comparison to Baseline	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.
6 Minute Walk Test distance [m] in comparison to Baseline.	3 years
Changes in heart failure related medication	3 years	reduction/increase of daily dose \[%\]
Relationship between pacemaker therapy and intra atrial shunt therapy	3 years

Trial Locations

Locations (14)

University Clinic Tübingen; 🇩🇪 Tübingen, Germany

CHU Besançon; 🇫🇷 Besançon, France

WKK Heide; 🇩🇪 Heide, Germany

CHU Montpellier; 🇫🇷 Montpellier, France

University Clinic; 🇩🇪 Cologne, Germany

CHU Lyon; 🇫🇷 Lyon, France

Knappschaftskrankenhaus Bottrop GmbH; 🇩🇪 Bottrop, Germany

Clinic Coburg; 🇩🇪 Coburg, Germany

University Clinic Jena; 🇩🇪 Jena, Germany

Cardiologicum Hamburg; 🇩🇪 Hamburg, Germany

Helios Clinic Erfurt; 🇩🇪 Erfurt, Germany

Clinic Osnabrück; 🇩🇪 Osnabrück, Germany

Elbe Clinic Stade; 🇩🇪 Stade, Germany

Hospital Osnabrueck; 🇩🇪 Osnabrück, Germany