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

Heart Failure Clinical Trial

— PRELIEVE  

Official title:

Prospective, Non-randomized, Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Heart Failure Patients With Reduced Ejection Fraction or in Heart Failure Patients With Preserved Ejection Fraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03030274
• Other study ID #: Occ2016_06
• Status: Completed
• Phase: N/A
• Start date: October 11, 2017
• Est. completion date: March 2, 2022

Study information

• Verified date: September 2022
• Source: Occlutech International AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 2, 2022
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria. Each patient must fulfill ALL of the following criteria and details:

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure Low Output

Intervention

Device:
• Occlutech AFR device
Catheter-guided placement of an AFR device following balloon atrial septostomy.

Locations

Country	Name	City	State
Belgium	Algemeen Stedelijk Ziekenhuis (Asz)	Aalst	Merestraat 80
Belgium	OLV (Onze-Lieve-Vrouwziekenhuis) Hospital Aalst	Aalst	Moorselbaan 164
Belgium	University Hospital Brussels	Brussels	Laarbeeklaan 101
Belgium	AZ Maria Middelares	Gent	Buitenring Sint-Denijs 30
Belgium	UZ Leuven	Leuven	Herestraat 49
Germany	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	Hannover
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
Turkey	Diskapi Yildirim Beyazit Egitim ve Arastirma Hastanesi	Ankara	Altindag
Turkey	Hacettepe Üni Hastanesi	Ankara	Altindag
Turkey	Bezmialem University	Istanbul
Turkey	Istanbul Üniversitesi	Istanbul	Fatih
Turkey	Kartal Kosuyolu Yüksek Ihtisas Egitim ve Arastirma Hastanesi	Istanbul	Kartal
Turkey	Ege Üniversitesi Hastanesi	Izmir	Bornova
Turkey	Izmir Kâtip Çelebi Üniversitesi	Izmir	Çigli
Turkey	Tepecik Egitim Ve Arastirma Hastanesi	Izmir	Konak
Turkey	Kocaeli Üniversitesi Hastanesi	Kocaeli
Turkey	Sivas Cumhuriyet Üniversitesi Tip Fakültesi Arastirma ve Uygulama Hastanesi	Sivas	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Occlutech International AB

Countries where clinical trial is conducted

Belgium,  Germany,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Device Effects (SADE) within 3 month following implantation.	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.	0-3 month
Secondary	Serious Adverse Device Effects (SADE) between 3-12 month following implantation	Incidence of all Serious Adverse Device Effects (SADE) following implantation	3-12 month
Secondary	Device placement	Device placement in situ	0-12 month
Secondary	Left to Right shunt through the AFR device	Evidence of Left to Right shunt through the AFR device	0-12 month