ProjectAFR-registry – Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the…

Basic data

Acronym:
AFR-registry
Title:
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
Duration:
11/6/2020 to 12/31/2025
Abstract / short description:
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.

Involved staff

Managers

Department of Internal Medicine
Hospitals and clinical institutes, Faculty of Medicine

Contact persons

Faculty of Medicine
University of Tübingen
Faculty of Medicine
University of Tübingen

Local organizational units

Internal Medicine Department III
Department of Internal Medicine
Hospitals and clinical institutes, Faculty of Medicine
Help

will be deleted permanently. This cannot be undone.