This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.
Written, informed consent
Age ≥18 years
Presence of chronic symptomatic HF (NYHA class ≥ 2)
Left Atrial Pressure (LAP) > Right Atrial Pressure (RAP); with a gradient equal or more than 5 mmHg*
Life expectancy < 1 year, or advanced heart failure defined as ACC/AHA Stage D heart failure, or listed for heart transplantation at time of baseline visit
Severe Right Ventricular Dysfunction (TAPSE < 14 mm)
Severe Right Ventricular Dilatation (RV volume ≥ LV volume)
Severe pulmonary hypertension (PASP > 60 mm Hg)
150 Heart Failure patients with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF), age ≥18 years, who gave their signed and dated informed consent will be included in the study analysis.
Case-only
Prospective
Occlutech Atrial Flow Regulator
DeviceThe Occlutech Atrial Flow Regulator is an interatrial shunt device for transcatheter delivery.
Rate of subjects with at least one Major Adverse Cardiovascular and Neurologic Events (MACNE) in the 1 year following implantation.
MACNE includes all-cause mortality, stroke, systemic thromboembolism, open cardiac surgery or major endovascular repair, and major bleeding (BARC 3-5).
Rate of subjects with at least one SAE/ (S)ADE at 12 months, 24 months and 36 months after implantation.
Cardiovascular Events at 12 months, 24 months and 36 months after implantation.
Heart Failure hospitalization rate; Cardiovascular mortality; Unplanned HF admission or treatment intensification.
Device performance at 12 months, 24 months and 36 months after implantation.
Device placed in situ as assessed by the investigator; Patency: evidence of LEFT TO RIGHT shunt through the AFR device; Implant embolization and clinically significant device migration.
NYHA class status in comparison to Baseline.
Click on the lead sponsor to view all of their trials.