The Prelieve Trial - Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Heart Failure Patients

Not Applicable

Completed

• Conditions: Heart Failure Low Output; Heart Failure
• Interventions: Device: Occlutech AFR device

• Registration Number: NCT03030274
• Lead Sponsor: Occlutech International AB

Brief Summary

This study aims to investigate safety and efficacy of the Occlutech® AFR device in patients with HFrEF (Heart failure with reduced ejection fraction) and HFpEF (Heart failure with preserved ejection fraction)

Detailed Description

This study will enroll subjects with HFrEF or HFpEF, until a maximum of 100 patients have undergone implantation with the Occlutech® AFR device.

Enrolled patients will be stratified according to their ejection fraction as either HFrEF (ejection fraction \> 15% and \<40 %) or HFpEF ( ejection Fraktion \> 40 % to 70 %). It is planned to enroll at least 100 patients per stratification subgroup.

Study Timeline

• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-24
• Study Start: 2017-10-11
• Primary Completion: 2021-05-01
• Study Completion: 2022-03-02
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Not provided

Exclusion Criteria

1. Local or generalized sepsis or other acute infection(s)

2. Any coagulation disorder, if clinically relevant in the opinion of the operator.

3. Allergy to nickel and/or titanium and/or nickel/titanium-based materials, if not medically manageable

4. Allergy to anti-platelet, -coagulant, or -thrombotic therapy, if not medically manageable

5. Intolerance to contrast agents, if not medically manageable

6. Participation in another medical trial testing a therapy less than 30 days before the intended AFR implantation procedure

7. Trans-oesophageal echocardiography and / or use of general anaesthetic is contraindicated

8. Breast feeding women

9. Pregnancy

   Processes which would technically disturb the safe intervention as planned:

10. Occluded inferior vena cava access

11. History of ASD and/or atrial septal repair or closure device in place

12. Intracardiac thrombus

    Clinical conditions:

13. Moderate valvular diseases requiring therapy according to current ESC guidelines. Patients are eligible in case therapy is formally indicated but cannot be performed due to technical or medial reasons if the latter is confirmed in writing by the PI in mutual agreement with the heart team and Severe aortic stenosis with valve area < 1.5cm² and Severe AR, TR or MR. Classification of severity of regurgitation should follow the definition provided in Lancelotti et al, Eur Heart J Cardiovasc Imaging 2013 [22]

14. Patients who has unstable and intractable angina pectoris

15. Evidence of right heart failure defined as (by ECHO)

    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)

16. Active malignancy

17. Severe valve disease, or implanted mechanical valve prosthesis

18. Congenital heart defect

19. Large PFO with significant atrial septal aneurysm (bubble test shows more than 20 bubbles)

20. Inability to perform 6-minutes walking test

21. Clinically relevant thrombocytopenia, thrombocytosis, leukopenia, or anemia

22. Symptomatic carotid artery disease

23. Mitral valve stenosis

24. Has any condition that, in the opinion of the Investigator, might interfere with the Implantation, might affect the patients well-being thereafter or might interfere with the conduct of the study

25. Systolic blood pressure of >170 mmHg, despite medical therapy

26. Severe lung disease (causing PHT with systolic PAP >60mmHg)

27. Pulmonary Hypertension (Systolic PAP >60mmHg)

28. TIA or stroke within the last 6 months

29. Scheduled for heart transplantation

30. Bleeding disorders (INR > 2.0, Thrombocytes < 100.000, Hemoglobin <8.0 gr/dl)

31. Myocardial infarction or percutaneous intervention or CABG (all within the last 3 month) or indication for a coronary intervention

32. Resyncronization therapy started within the last 6 months

33. Aneurysm of the septum

34. Hypertrophied Inter Atrial Septum (IAS) > 10mm depth

35. Hypertrophic Obstructive Cardiomyopathy (HOCM) or infiltrative CM as cause of HF

36. Thromboembolic events within the last 6 months

37. Dialysis and renal insufficiency requiring dialysis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Occlutech AFR Device	Occlutech AFR device	Prospective, non-randomized, pilot study to assess safety and efficacy of a novel Atrial Flow Regulator in Heart Failure Patients with with reduced Ejection Fraction (HFrEF) and Heart Failure Patients with preserved Ejection Fraction (HFpEF); the AFR-Prelieve Trial

Primary Outcome Measures

Name	Time	Method
Serious Adverse Device Effects (SADE) within 3 month following implantation.	0-3 month	Incidence of Serious Adverse Device Effects (SADE) following implantation such as: * device dislocation / embolization; * damage to the tricuspid or mitral valve caused by the device; * intractable arrhythmias caused by the device; * any circumstances that require device removal.

Secondary Outcome Measures

Name	Time	Method
Device placement	0-12 month	Device placement in situ
Serious Adverse Device Effects (SADE) between 3-12 month following implantation	3-12 month	Incidence of all Serious Adverse Device Effects (SADE) following implantation
Left to Right shunt through the AFR device	0-12 month	Evidence of Left to Right shunt through the AFR device

Trial Locations

Locations (26)

University Hospital Brussels; 🇧🇪 Brussels, Laarbeeklaan 101, Belgium

AZ Maria Middelares; 🇧🇪 Gent, Buitenring Sint-Denijs 30, Belgium

UZ Leuven; 🇧🇪 Leuven, Herestraat 49, Belgium

Algemeen Stedelijk Ziekenhuis (Asz); 🇧🇪 Aalst, Merestraat 80, Belgium

OLV (Onze-Lieve-Vrouwziekenhuis) Hospital Aalst; 🇧🇪 Aalst, Moorselbaan 164, Belgium

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Vivantes Klinikum im Friedrichshain; 🇩🇪 Berlin, Germany

Herzzentrum Uniklinik Köln; 🇩🇪 Cologne, Germany

CardioVasculäres Centrum Frankfurt; 🇩🇪 Frankfurt, Germany

University of Homburg; 🇩🇪 Homburg, Germany

Cardiologicum Hamburg; 🇩🇪 Hamburg, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Herzzentrum Leipzig; 🇩🇪 Leipzig, Germany

Uniklinikum Magdeburg A. ö. R.; 🇩🇪 Magdeburg, Germany

Universitätsmedizin Rostock; 🇩🇪 Rostock, Germany

University of Würzburg; 🇩🇪 Würzburg, Germany

Hacettepe Üni Hastanesi; 🇹🇷 Ankara, Altındağ, Turkey

Dışkapı Yıldırım Beyazıt Eğitim ve Araştırma Hastanesi; 🇹🇷 Ankara, Altındağ, Turkey

Ege Üniversitesi Hastanesi; 🇹🇷 İzmir, Bornova, Turkey

Tepecik Eğitim Ve Araştırma Hastanesi; 🇹🇷 İzmir, Konak, Turkey

İstanbul Üniversitesi; 🇹🇷 Istanbul, Fatih, Turkey

Bezmialem University; 🇹🇷 Istanbul, Turkey

Kocaeli Üniversitesi Hastanesi; 🇹🇷 Kocaeli, Turkey

İzmir Kâtip Çelebi Üniversitesi; 🇹🇷 İzmir, Çiğli, Turkey

Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştırma Hastanesi; 🇹🇷 Istanbul, Kartal, Turkey

Sivas Cumhuriyet Üniversitesi Tıp Fakültesi Araştırma ve Uygulama Hastanesi; 🇹🇷 Sivas, Merkez, Turkey