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

September 13, 2022 updated by: Occlutech International AB

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Buitenring Sint-Denijs 30
      • Gent, Buitenring Sint-Denijs 30, Belgium, 9000
        • AZ Maria Middelares
    • Herestraat 49
      • Leuven, Herestraat 49, Belgium, 3000
        • UZ Leuven
    • Laarbeeklaan 101
      • Brussels, Laarbeeklaan 101, Belgium, 1090
        • University Hospital Brussels
    • Merestraat 80
      • Aalst, Merestraat 80, Belgium, 9300
        • Algemeen Stedelijk Ziekenhuis (Asz)
    • Moorselbaan 164
      • Aalst, Moorselbaan 164, Belgium, 9300
        • OLV (Onze-Lieve-Vrouwziekenhuis) Hospital Aalst
  • Germany
      • Berlin, Germany
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany
        • Vivantes Klinikum im Friedrichshain
      • Cologne, Germany
        • Herzzentrum Uniklinik Köln
      • Frankfurt, Germany
        • CardioVasculäres Centrum Frankfurt
      • Hamburg, Germany
        • Cardiologicum Hamburg
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Homburg, Germany
        • University of Homburg
      • Leipzig, Germany
        • Herzzentrum Leipzig
      • Magdeburg, Germany
        • Uniklinikum Magdeburg A. ö. R.
      • Rostock, Germany
        • Universitätsmedizin Rostock
      • Würzburg, Germany
        • University of Würzburg
  • Turkey
      • Istanbul, Turkey
        • Bezmialem University
      • Kocaeli, Turkey
        • Kocaeli Universitesi Hastanesi
    • Altındağ
      • Ankara, Altındağ, Turkey, 06110
        • Dışkapı Yıldırım Beyazıt Eğitim ve Araştırma Hastanesi
      • Ankara, Altındağ, Turkey, 06230
        • Hacettepe Üni Hastanesi
    • Bornova
      • İzmir, Bornova, Turkey
        • Ege Universitesi Hastanesi
    • Fatih
      • Istanbul, Fatih, Turkey, 34452
        • Istanbul Universitesi
    • Kartal
      • Istanbul, Kartal, Turkey, 34865
        • Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştırma Hastanesi
    • Konak
      • İzmir, Konak, Turkey, 35020
        • Tepecik Eğitim Ve Araştırma Hastanesi
    • Merkez
      • Sivas, Merkez, Turkey, 58140
        • Sivas Cumhuriyet Üniversitesi Tıp Fakültesi Araştırma ve Uygulama Hastanesi
    • Çiğli
      • İzmir, Çiğli, Turkey, 35620
        • İzmir Katip Çelebi Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Device: Occlutech AFR device
Catheter-guided placement of an AFR device following balloon atrial septostomy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serious Adverse Device Effects (SADE) within 3 month following implantation.
Time Frame: 0-3 month

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serious Adverse Device Effects (SADE) between 3-12 month following implantation
Time Frame: 3-12 month
Incidence of all Serious Adverse Device Effects (SADE) following implantation
3-12 month
Device placement
Time Frame: 0-12 month
Device placement in situ
0-12 month
Left to Right shunt through the AFR device
Time Frame: 0-12 month
Evidence of Left to Right shunt through the AFR device
0-12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Occlutech International AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Occ2016_06

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Publications
    Information identifier: NCT03030274
    Information comments: 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
  2. Publications
    Information identifier: NCT03030274
    Information comments: 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
  3. Publiactions
    Information identifier: NCT03030274
    Information comments: Nijad Bakhshaliyev 1, Ramazan Ozdemir 1_The impact of atrial flow regulator implantation on hemodynamic parameters in patients with heart failure

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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