NCT04405583

The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients

A Multicentre, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech Atrial Flow Regulator in Heart Failure Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Occlutech International AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.

Detailed description

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 over a follow-up period of 36 month 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Occlutech Atrial Flow Regulator	The Occlutech Atrial Flow Regulator is an interatrial shunt device for transcatheter delivery.

Timeline

• Start date: 2020-10-28
• Primary completion: 2027-06-30
• Completion: 2027-10-01
• First posted: 2020-05-28
• Last updated: 2026-01-29

Locations

36 sites across 8 countries: France, Germany, Greece, Italy, Portugal, Serbia, Tunisia, Turkey (Türkiye)