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

NCT ID: NCT03030274

Last Updated: 2022-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-11
• Study Completion Date: 2022-03-02

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.

Conditions

Heart Failure Low Output; Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Occlutech AFR device

Intervention Type: DEVICE

Catheter-guided placement of an AFR device following balloon atrial septostomy.

Interventions

Occlutech AFR device

Catheter-guided placement of an AFR device following balloon atrial septostomy.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years

2. Heart failure resulting in NYHA class III or IV ambulatory

3. Ongoing management of heart failure according to ESC (European Society of Cardiology) (15) -guidelines during previous ≥6 months

4. Control with Arrhythmia with heart rate <110bpm

5. Life expectancy of at least 1 year

6. The patient should have the ability to fluently speak and understand the language in which the study is being conducted

7. Written, informed consent by the patient for participation in the study and agreement to comply with the follow-up schedule

8. Patient has had a successful Balloon Atrial Septostomy (BAS) procedure and is in a stable hemodynamic state, as assessed by the investigator

9. LVEF ≥15% and ≤ 70% , EF measured via Echocardiography 9.1.9.1. And for LVEF ≥ 40% (HFpEF): elevated NT-pro-BNP of ≥ 125 pg/ml

10. Elevated left ventricular filling pressure documented by 10.1. Either Pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure at rest ≥ 15 mmHg and greater then central venous preassure (CVP) 10.2. 10.2. Or: End-expiratory PCWP ≥25 mmHg at exercise and CVP <20 mm Hg

11. Transseptal catheterization and femoral vein access is determined to be feasible

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Occlutech International AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AZ Maria Middelares

Ghent, Buitenring Sint-Denijs 30, Belgium

UZ Leuven

Leuven, Herestraat 49, Belgium

University Hospital Brussels

Brussels, Laarbeeklaan 101, 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

Cardiologicum Hamburg

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

University of Homburg

Homburg, , Germany

Herzzentrum Leipzig

Leipzig, , Germany

Uniklinikum Magdeburg A. ö. R.

Magdeburg, , Germany

Universitätsmedizin Rostock

Rostock, , Germany

University of Würzburg

Würzburg, , Germany

Dışkapı Yıldırım Beyazıt Eğitim ve Araştırma Hastanesi

Ankara, Altındağ, Turkey (Türkiye)

Hacettepe Üni Hastanesi

Ankara, Altındağ, Turkey (Türkiye)

Ege Üniversitesi Hastanesi

Izmir, Bornova, Turkey (Türkiye)

İstanbul Üniversitesi

Istanbul, Fatih, Turkey (Türkiye)

Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Istanbul, Kartal, Turkey (Türkiye)

Tepecik Eğitim Ve Araştırma Hastanesi

Izmir, Konak, Turkey (Türkiye)

Sivas Cumhuriyet Üniversitesi Tıp Fakültesi Araştırma ve Uygulama Hastanesi

Sivas, Merkez, Turkey (Türkiye)

Bezmialem University

Istanbul, , Turkey (Türkiye)

Kocaeli Üniversitesi Hastanesi

Kocaeli, , Turkey (Türkiye)

İzmir Kâtip Çelebi Üniversitesi

Izmir, Çiğli, Turkey (Türkiye)

Countries

Belgium; Germany; Turkey (Türkiye)

References

Lauder L, Bergmann MW, Paitazoglou C, Ozdemir R, Iliadis C, Bartunek J, Lauten A, Keller T, Weber S, Sievert H, Anker SD, Mahfoud F. Predicted impact of atrial flow regulator on survival in heart failure with reduced and preserved ejection fraction. ESC Heart Fail. 2023 Aug;10(4):2559-2566. doi: 10.1002/ehf2.14384. Epub 2023 Jun 13.

Reference Type: DERIVED

PMID: 37312287 (View on PubMed)

Study Documents

Document Type: Publications

Christina Paitazoglou 1, Ramazan Özdemir, Roman Pfister, Martin W Bergmann, Jozef Bartunek, Teoman Kilic, Alexander Lauten, Alexander Schmeisser, Mehdi Zoghi, Stefan Anker, Horst Sievert, Felix Mahfoud\_The AFR-PRELIEVE trial: a prospective, non-randomised, pilot study to assess the Atrial Flow Regulator (AFR) in heart failure patients with either preserved or reduced ejection fraction

View Document

Document Type: Publications

Christina Paitazoglou 1, Martin W Bergmann 1, Ramazan Özdemir 2, Roman Pfister 3, Jozef Bartunek 4, Teoman Kilic 5, Alexander Lauten 6, Alexander Schmeisser 7, Mehdi Zoghi 8, Stefan D Anker 6, Horst Sievert 9, Felix Mahfoud 10, AFR-PRELIEVE Investigators\_One-year results of the first-in-man study investigating the Atrial Flow Regulator for left atrial shunting in symptomatic heart failure patients: the PRELIEVE study

View Document

Document Type: Publiactions

Nijad Bakhshaliyev 1, Ramazan Ozdemir 1\_The impact of atrial flow regulator implantation on hemodynamic parameters in patients with heart failure

View Document

Other Identifiers

Occ2016_06

Identifier Type: -

Identifier Source: org_study_id