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Heart Failure Low OutputPRELIEVENCT03030274

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

A study testing Occlutech AFR device in people with Heart Failure Low Output and Heart Failure, run by Occlutech International AB at 26 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure Low Output, Heart Failure
What is being tested?
Occlutech AFR device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
26 sitesin 3 countries
Study dates
11 Oct 2017to 2 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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
Show all 42Show fewer
  • 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]
  • Patients who has unstable and intractable angina pectoris
  • Evidence of right heart failure defined as (by ECHO)
  • Severe Right Ventricular Dysfunction (TAPSE < 14 mm)
  • Severe Right Ventricular Dilatation (RV volume ≥ LV volume)
  • Severe pulmonary hypertension (PASP > 60 mm Hg)
  • Active malignancy
  • Severe valve disease, or implanted mechanical valve prosthesis
  • Congenital heart defect
  • Large PFO with significant atrial septal aneurysm (bubble test shows more than 20 bubbles)
  • Inability to perform 6-minutes walking test
  • Clinically relevant thrombocytopenia, thrombocytosis, leukopenia, or anemia
  • Symptomatic carotid artery disease
  • Mitral valve stenosis
  • 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
  • Systolic blood pressure of >170 mmHg, despite medical therapy
  • Severe lung disease (causing PHT with systolic PAP >60mmHg)
  • Pulmonary Hypertension (Systolic PAP >60mmHg)
  • TIA or stroke within the last 6 months
  • Scheduled for heart transplantation
  • Bleeding disorders (INR > 2.0, Thrombocytes < 100.000, Hemoglobin <8.0 gr/dl)
  • Myocardial infarction or percutaneous intervention or CABG (all within the last 3 month) or indication for a coronary intervention
  • Resyncronization therapy started within the last 6 months
  • Aneurysm of the septum
  • Hypertrophied Inter Atrial Septum (IAS) > 10mm depth
  • Hypertrophic Obstructive Cardiomyopathy (HOCM) or infiltrative CM as cause of HF
  • Thromboembolic events within the last 6 months
  • Dialysis and renal insufficiency requiring dialysis

Trial locations and contacts

26 sites in 3 countries.

26 sites in 3 countries

Germany11 sites

  • Charité - Universitätsmedizin Berlin

    Berlin

  • Vivantes Klinikum im Friedrichshain

    Berlin

  • Herzzentrum Uniklinik Köln

    Cologne

  • CardioVasculäres Centrum Frankfurt

    Frankfurt

  • Cardiologicum Hamburg

    Hamburg

  • Medizinische Hochschule Hannover

    Hanover

  • University of Homburg

    Homburg

  • Herzzentrum Leipzig

    Leipzig

  • Uniklinikum Magdeburg A. ö. R.

    Magdeburg

  • Universitätsmedizin Rostock

    Rostock

  • University of Würzburg

    Würzburg

Other trials in Germany

Turkey (Türkiye)10 sites

  • Dışkapı Yıldırım Beyazıt Eğitim ve Araştırma Hastanesi

    Ankara, Altındağ, 06110

  • Hacettepe Üni Hastanesi

    Ankara, Altındağ, 06230

  • İstanbul Üniversitesi

    Istanbul, Fatih, 34452

  • Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştırma Hastanesi

    Istanbul, Kartal, 34865

  • Bezmialem University

    Istanbul

  • Ege Üniversitesi Hastanesi

    Izmir, Bornova

  • Tepecik Eğitim Ve Araştırma Hastanesi

    Izmir, Konak, 35020

  • İzmir Kâtip Çelebi Üniversitesi

    Izmir, Çiğli, 35620

  • Kocaeli Üniversitesi Hastanesi

    Kocaeli

  • Sivas Cumhuriyet Üniversitesi Tıp Fakültesi Araştırma ve Uygulama Hastanesi

    Sivas, Merkez, 58140

Other trials in Turkey (Türkiye)

Belgium5 sites

  • Algemeen Stedelijk Ziekenhuis (Asz)

    Aalst, Merestraat 80, 9300

  • OLV (Onze-Lieve-Vrouwziekenhuis) Hospital Aalst

    Aalst, Moorselbaan 164, 9300

  • University Hospital Brussels

    Brussels, Laarbeeklaan 101, 1090

  • AZ Maria Middelares

    Ghent, Buitenring Sint-Denijs 30, 9000

  • UZ Leuven

    Leuven, Herestraat 49, 3000

Other trials in Belgium

About this study

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

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)

Read the 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.

Being tested
Occlutech AFR device
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Occlutech AFR deviceDevice

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

Study groups in NCT03030274
Study groupRoleWhat they receive
Occlutech AFR DeviceExperimentalProspective, 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
Receives: Device: Occlutech AFR device

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 0-3 month

Secondary outcomes (3)

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

    Incidence of all Serious Adverse Device Effects (SADE) following implantation

    Measured: 3-12 month

  2. Device placement

    Device placement in situ

    Measured: 0-12 month

  3. Left to Right shunt through the AFR device

    Evidence of Left to Right shunt through the AFR device

    Measured: 0-12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2017 (estimated)
  2. Study start11 Oct 2017
  3. Primary completion1 May 2021
  4. Study completion2 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03030274
Sponsor's protocol ID
Occ2016_06
Acronym
PRELIEVE
Status last verified
Sep 2022
First submitted
17 Jan 2017
Last updated
15 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37312287

Questions about this trial

What is this clinical trial studying?

A study testing Occlutech AFR device in people with Heart Failure Low Output and Heart Failure, run by Occlutech International AB at 26 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Germany, Turkey (Türkiye), Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serious Adverse Device Effects (SADE) within 3 month following implantation. (time frame: 0-3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03030274, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.

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