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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 (NCT03030274)

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)
  • Device: Occlutech AFR device
    Catheter-guided placement of an AFR device following balloon atrial septostomy.
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Inclusion criteria. Each patient must fulfill ALL of the following criteria and details:
    • Age ≥18 years
    • NYHA-Class III or IV ambulatory
    • Ongoing management of heart failure according to ESC (European Society of Cardiology) -guidelines during previous ≥6 months
    • Symptomatic heart failure resulting in at least one hospitalization in the past 12 months
    • Absence of moderate valvular diseases who require specific therapy (as per ESC guidance)
    • Control of arrhythmia with heart rate <90bpm
    • 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 Data by echocardiography:
    • LVEF ≥15% and ≤55%
    • Elevated left ventricular filling pressure
    • Transseptal catheterization and femoral vein access is determined to be feasible
    Exclusion Criteria:
    • 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
    • Occluded inferior vena cava access
    • History of ASD and/or atrial septal repair or closure device in place
    • Intracardiac thrombus
    • Patients who has unstable and intractable angina pectoris
    • Evidence of right heart failure defined as (by ECHO)
    • Severe Right Ventricular Dysfunction
    • Severe Right Ventricular Dilatation
    • Severe pulmonary hypertension
    • Active malignancy
    • Severe valve disease, or implanted mechanical valve prosthesis
    • Congenital heart defect
    • Large PFO with significant atrial septal aneurysm
    • Resting heart rate >110 bpm
    • 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 >60)
    • Pulmonary Hypertension (Systolic PAP >60)
    • TIA or stroke within the last 6 months
    • Scheduled for heart transplantation
    • Bleeding disorders
    • Myocardial infarction or percutaneous intervention or CABG (all within the last 3 month) or indication for a coronary intervention
    • Resynchronization therapy started within the last 6 months
    • Aneurysm of the septum
    • Hypertrophied Inter Atrial Septum (IAS)
    • Hypertrophic Cardiomyopathy (HCM) or infiltrative CM as cause of HF
    • Thromboembolic events within the last 6 months
    • Dialysis and renal insufficiency requiring dialysis

    1 locations

    Germany (1)
    • Cardiovascular Center Frankfurt
      recruiting
      Frankfurt am Main, Germany, 60389
    Status:
    recruiting
    Type:
    Interventional
    Phase:
    -
    Start:
    05 July, 2017
    Updated:
    13 August, 2017
    Participants:
    30
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