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

NCT03030274 | Completed

• 1 other identifier: Occ2016_06
• Study Type: interventional
• Target: 106
• Locations: 3 countries
• Sites: 26

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)

Conditions

Heart Failure Low Output; Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Serious Adverse Device Effects (SADE) between 3-12 month following implantation

  3-12 month

• Device placement

  0-12 month

• Left to Right shunt through the AFR device

  0-12 month

Study Arms (1)

Occlutech AFR Device

EXPERIMENTAL

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

Device: Occlutech AFR device

Interventions

Occlutech AFR device DEVICE

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

Occlutech AFR Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Heart failure resulting in NYHA class III or IV ambulatory
• Ongoing management of heart failure according to ESC (European Society of Cardiology) (15) -guidelines during previous ≥6 months
• Control with Arrhythmia with heart rate \<110bpm
• Life expectancy of at least 1 year
• The patient should have the ability to fluently speak and understand the language in which the study is being conducted
• Written, informed consent by the patient for participation in the study and agreement to comply with the follow-up schedule
• Patient has had a successful Balloon Atrial Septostomy (BAS) procedure and is in a stable hemodynamic state, as assessed by the investigator
• 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
• 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
• Transseptal catheterization and femoral vein access is determined to be feasible

You may not qualify if:

• Local or generalized sepsis or other acute infection(s)
• Any coagulation disorder, if clinically relevant in the opinion of the operator.
• Allergy to nickel and/or titanium and/or nickel/titanium-based materials, if not medically manageable
• Allergy to anti-platelet, -coagulant, or -thrombotic therapy, if not medically manageable
• Intolerance to contrast agents, if not medically manageable
• Participation in another medical trial testing a therapy less than 30 days before the intended AFR implantation procedure
• Trans-oesophageal echocardiography and / or use of general anaesthetic is contraindicated
• Breast feeding women
• Pregnancy
• Processes which would technically disturb the safe intervention as planned:
• Occluded inferior vena cava access
• History of ASD and/or atrial septal repair or closure device in place
• Intracardiac thrombus
• Clinical conditions:
• 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 \[22\]

Sponsors & Collaborators

• Occlutech International AB: lead

Study Sites (26)

AZ Maria Middelares

Ghent, Buitenring Sint-Denijs 30, 9000, Belgium

Location

UZ Leuven

Leuven, Herestraat 49, 3000, Belgium

Location

University Hospital Brussels

Brussels, Laarbeeklaan 101, 1090, Belgium

Location

Algemeen Stedelijk Ziekenhuis (Asz)

Aalst, Merestraat 80, 9300, Belgium

Location

OLV (Onze-Lieve-Vrouwziekenhuis) Hospital Aalst

Aalst, Moorselbaan 164, 9300, Belgium

Location

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Vivantes Klinikum im Friedrichshain

Berlin, Germany

Location

Herzzentrum Uniklinik Köln

Cologne, Germany

Location

CardioVasculäres Centrum Frankfurt

Frankfurt, Germany

Location

Cardiologicum Hamburg

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

University of Homburg

Homburg, Germany

Location

Herzzentrum Leipzig

Leipzig, Germany

Location

Uniklinikum Magdeburg A. ö. R.

Magdeburg, Germany

Location

Universitätsmedizin Rostock

Rostock, Germany

Location

University of Würzburg

Würzburg, Germany

Location

Dışkapı Yıldırım Beyazıt Eğitim ve Araştırma Hastanesi

Ankara, Altındağ, 06110, Turkey (Türkiye)

Location

Hacettepe Üni Hastanesi

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

Ege Üniversitesi Hastanesi

Izmir, Bornova, Turkey (Türkiye)

Location

İstanbul Üniversitesi

Istanbul, Fatih, 34452, Turkey (Türkiye)

Location

Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Istanbul, Kartal, 34865, Turkey (Türkiye)

Location

Tepecik Eğitim Ve Araştırma Hastanesi

Izmir, Konak, 35020, Turkey (Türkiye)

Location

Sivas Cumhuriyet Üniversitesi Tıp Fakültesi Araştırma ve Uygulama Hastanesi

Sivas, Merkez, 58140, Turkey (Türkiye)

Location

Bezmialem University

Istanbul, Turkey (Türkiye)

Location

Kocaeli Üniversitesi Hastanesi

Kocaeli, Turkey (Türkiye)

Location

İzmir Kâtip Çelebi Üniversitesi

Izmir, Çiğli, 35620, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 37312287 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 24, 2017
• Study Start: October 11, 2017
• Primary Completion: May 1, 2021
• Study Completion: March 2, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

TU (10); BE (5); DE (11)