Clinical trial NCT03030274: The Prelieve Trial - Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Heart Failure Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure Low Output
Heart Failure
Lead sponsor: Occlutech International AB
Sponsor class: INDUSTRY
First posted: 2017-01-24
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serious Adverse Device Effects (SADE) within 3 month following implantation.
timeFrame: 0-3 month
Secondary outcomes:
measure: Serious Adverse Device Effects (SADE) between 3-12 month following implantation
timeFrame: 3-12 month
measure: Device placement
timeFrame: 0-12 month
measure: Left to Right shunt through the AFR device
timeFrame: 0-12 month
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Maria Middelares
state: Buitenring Sint-Denijs 30
city: Leuven
country: Belgium
facility: UZ Leuven
state: Herestraat 49
city: Brussels
country: Belgium
facility: University Hospital Brussels
state: Laarbeeklaan 101
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis (Asz)
state: Merestraat 80
city: Aalst
country: Belgium
facility: OLV (Onze-Lieve-Vrouwziekenhuis) Hospital Aalst
state: Moorselbaan 164
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshain
city: Cologne
country: Germany
facility: Herzzentrum Uniklinik Köln
city: Frankfurt
country: Germany
facility: CardioVasculäres Centrum Frankfurt
city: Hamburg
country: Germany
facility: Cardiologicum Hamburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Homburg
country: Germany
facility: University of Homburg
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Magdeburg
country: Germany
facility: Uniklinikum Magdeburg A. ö. R.
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock
city: Würzburg
country: Germany
facility: University of Würzburg
city: Ankara
country: Turkey
facility: Dışkapı Yıldırım Beyazıt Eğitim ve Araştırma Hastanesi
state: Altındağ
city: Ankara
country: Turkey
facility: Hacettepe Üni Hastanesi
state: Altındağ
city: İzmir
country: Turkey
facility: Ege Üniversitesi Hastanesi
state: Bornova
city: Istanbul
country: Turkey
facility: İstanbul Üniversitesi
state: Fatih
city: Istanbul
country: Turkey
facility: Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştırma Hastanesi
state: Kartal
city: İzmir
country: Turkey
facility: Tepecik Eğitim Ve Araştırma Hastanesi
state: Konak
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet Üniversitesi Tıp Fakültesi Araştırma ve Uygulama Hastanesi
state: Merkez
city: Istanbul
country: Turkey
facility: Bezmialem University
city: Kocaeli
country: Turkey
facility: Kocaeli Üniversitesi Hastanesi
city: İzmir
country: Turkey
facility: İzmir Kâtip Çelebi Üniversitesi
state: Çiğli
Study officials:
References: