NCT03030274CompletedNot Applicable
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
Occlutech International AB26 sites in 3 countries106 target enrollmentStarted: October 11, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Occlutech International AB
- Enrollment
- 106
- Locations
- 26
- Primary Endpoint
- Serious Adverse Device Effects (SADE) within 3 month following implantation.
Study Overview
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)
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •. Each patient must fulfill ALL of the following criteria and details:
- •Age ≥18 years
- •Heart failure resulting in NYHA class III or IV ambulatory
- •Ongoing management of heart failure according to ESC (European Society of Cardiology) (15) -guidelines during previous ≥6 months
- •Control with Arrhythmia with heart rate <110bpm
- •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
- •LVEF ≥15% and ≤ 70% , EF measured via Echocardiography 9.1.9.
- •And for LVEF ≥ 40% (HFpEF): elevated NT-pro-BNP of ≥ 125 pg/ml
- •Elevated left ventricular filling pressure documented by 10.
- •Either Pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure at rest ≥ 15 mmHg and greater then central venous preassure (CVP) 10.
- •Or: End-expiratory PCWP ≥25 mmHg at exercise and CVP <20 mm Hg
- •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
- •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
Arms & Interventions
Occlutech AFR Device
Experimental
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
Intervention: Occlutech AFR device (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Device placement(0-12 month)
- Serious Adverse Device Effects (SADE) between 3-12 month following implantation(3-12 month)
- Left to Right shunt through the AFR device(0-12 month)
Investigators
Study Sites (26)
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