AFR-registry

Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech®Atrial Flow Regulator in Heart Failure Patients– THE AFR- AFTER REGISTRY –The AFR- AFteR Registry CIP Version 1.1 final dated 26 May 2020

06/11/2020 to 31/12/2025

Study purpose: This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.
Study design: This is a prospective, multicentre, international, follow–up registry to monitor the safety and the performance of the Occlutech AFR device in patients with Heart Failure, to identify unknown side effects and to assess the indications and contraindications for an AFR treatment.
• Efficacy and safety of implanted device(s) will be evaluated by vital signs, laboratory test, quality of life questionnaire, ECG, and echocardiography data on Day 1 (within 36 hrs. post procedure), 3 months, 12 months, 24 months and 36 months after implantation.
• Patients will be treated according to the instruction-for-use of the device and according to clinical routine. Procedures will be performed at sites having appropriate laboratory support and adequately trained imaging personnel. Procedures will be performed by physicians with experience in a wide range of interventional cardiology and structural heart disease.

Study objectives:
Primary objectives - Safety
To evaluate the safety and tolerability of the Occlutech AFR device in patients with Heart Failure by assessing the rate of patients with at least one Severe Adverse Device Effect (SADE) 12 months after implantation.
Secondary objectives - Safety:
To evaluate the safety and tolerability of the Occlutech AFR device in patients with Heart Failure by assessing the rate of patients with at least one SADE 3- ,12-,24-, and 36 months following implantation.
Effectiveness
To evaluate the improvement of patient symptoms at Day 1 (within 36 hrs. post procedure), 3 months, 12 months, 24 months, and 36 months following implantation.