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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030274
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Occlutech International AB

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)

Condition or disease Intervention/treatment Phase
Heart Failure Low Output Heart Failure Device: Occlutech AFR device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 6, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Occlutech AFR Device
Prospective, multicenter, open-label, non-randomized pilot study to assess safety and efficacy of implantation of the Occlutech® AFR device in patients with HFrEF and HFp
Device: Occlutech AFR device
Catheter-guided placement of an AFR device following balloon atrial septostomy.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Device placement [ Time Frame: 0-12 month ]
    Device placement in situ

  3. Left to Right shunt through the AFR device [ Time Frame: 0-12 month ]
    Evidence of Left to Right shunt through the AFR device



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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. Or: End-expiratory >25mmHg 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030274


Contacts
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Contact: Gönül Sönmez Utkun +902124650497 clinicaltrials@occlutech.com

Locations
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Germany
Cardiovascular Center Frankfurt Recruiting
Frankfurt am Main, Germany, 60389
Contact: Horst Sievert, Prof.         
Sponsors and Collaborators
Occlutech International AB
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Responsible Party: Occlutech International AB
ClinicalTrials.gov Identifier: NCT03030274    
Other Study ID Numbers: Occ2016_06
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases