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Trial record 2 of 44 for:    afr

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 : March 28, 2019
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : December 2019
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 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. NYHA-Class III or IV ambulatory
  3. Ongoing management of heart failure according to ESC (European Society of Cardiology) -guidelines during previous ≥6 months
  4. Symptomatic heart failure resulting in at least one hospitalization in the past 12 months
  5. Absence of moderate valvular diseases who require specific therapy (as per ESC guidance)
  6. Control of arrhythmia with heart rate <90bpm
  7. Life expectancy of at least 1 year
  8. The patient should have the ability to fluently speak and understand the language in which the study is being conducted
  9. Written, informed consent by the patient for participation in the study and agreement to comply with the follow-up schedule
  10. Patient has had a successful Balloon Atrial Septostomy (BAS) procedure and is in a stable hemodynamic state, as assessed by the investigator

    Data by echocardiography:

  11. LVEF ≥15% and ≤55%
  12. Elevated left ventricular filling pressure
  13. 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
  10. Occluded inferior vena cava access
  11. History of ASD and/or atrial septal repair or closure device in place
  12. Intracardiac thrombus
  13. Patients who has unstable and intractable angina pectoris
  14. Evidence of right heart failure defined as (by ECHO)

    • Severe Right Ventricular Dysfunction
    • Severe Right Ventricular Dilatation
    • Severe pulmonary hypertension
  15. Active malignancy
  16. Severe valve disease, or implanted mechanical valve prosthesis
  17. Congenital heart defect
  18. Large PFO with significant atrial septal aneurysm
  19. Resting heart rate >110 bpm
  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 >60)
  27. Pulmonary Hypertension (Systolic PAP >60)
  28. TIA or stroke within the last 6 months
  29. Scheduled for heart transplantation
  30. Bleeding disorders
  31. Myocardial infarction or percutaneous intervention or CABG (all within the last 3 month) or indication for a coronary intervention
  32. Resynchronization therapy started within the last 6 months
  33. Aneurysm of the septum
  34. Hypertrophied Inter Atrial Septum (IAS)
  35. Hypertrophic Cardiomyopathy (HCM) 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: Thomas Schöndorf +49(0)3641 67 51 20 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: March 28, 2019
Last Verified: March 2019

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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