The Prelieve Trial - Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (… (NCT03030274) | Clinical Trial Compass
CompletedNot Applicable
The Prelieve Trial - Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Heart Failure Patients
Belgium106 participantsStarted 2017-10-11
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
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
✕
What they're measuring
1
Serious Adverse Device Effects (SADE) within 3 month following implantation.