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
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Locations near you
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Full eligibility criteria for NCT03030274
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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. And for LVEF > 40%
(HFpEF): elevated NT-pro-BNP of > 125 pg/ml
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
Transseptal catheterization and femoral vein access is determined to be feasible
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 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 
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)
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)
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
All locations for NCT03030274
Cardiovascular Center Frankfurt
Frankfurt am Main, Germany, 60389
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View full eligibility
Tris trial is registered with FDA with number: NCT03030274. The sponsor of the trial is Occlutech International AB and it is looking for 30 volunteers for the current phase.
Official trial 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
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