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

This study aims to monitor the safety and effectiveness of the Occlutech AFR device in patients with heart failure for 3 years following AFR device implantation.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: Occlutech Atrial Flow Regulator

Detailed Description

Prospective, multicentre, international, follow-up registry to monitor the safety and the performance of the Occlutech AFR device in patients with Heart Failure, evaluated by vital signs, laboratory tests, quality of life questionnaire, ECG, and echocardiography data. Patients will be treated according to the instruction-for-use of the device and according to clinical routine by experienced physicians.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Inga-Maria Wefel; Phone Number: +49 171 715 85 88; Email: dl_occlutech_clinical_team_eu-ist@occlutech.com
• Study Contact Backup: Name: Gonul Sonmez Utkun; Phone Number: +90 542 826 11 95; Email: dl_occlutech_clinical_team_eu-ist@occlutech.com

Study Locations

• France
  • Besançon, France
    • Not yet recruiting
    • CHU Besançon
  • Lyon, France
    • Recruiting
    • CHU Lyon
  • Montpellier, France
    • Recruiting
    • CHU Montpellier
• Germany
  • Bottrop, Germany
    • Not yet recruiting
    • Knappschaftskrankenhaus Bottrop GmbH
    • Principal Investigator: Martin Christ, MD
  • Coburg, Germany
    • Recruiting
    • Clinic Coburg
  • Cologne, Germany
    • Recruiting
    • University Clinic
  • Erfurt, Germany
    • Active, not recruiting
    • Helios Clinic Erfurt
  • Hamburg, Germany
    • Active, not recruiting
    • Cardiologicum Hamburg
  • Heide, Germany
    • Recruiting
    • WKK Heide
  • Jena, Germany
    • Recruiting
    • University Clinic Jena
  • Osnabrück, Germany
    • Recruiting
    • Hospital Osnabrueck
  • Osnabrück, Germany
    • Recruiting
    • Clinic Osnabrück
  • Stade, Germany
    • Recruiting
    • Elbe Clinic Stade
  • Tübingen, Germany
    • Active, not recruiting
    • University clinic Tübingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will enroll 100 Patients with Heart Failure over 18 years of age, for whom AFR Implantation is indicated and planned.

Description

Inclusion Criteria:

• Patients for whom Occlutech AFR Implantation is indicated and planned
• Age 18 years or older
• Written informed consent is available

Exclusion Criteria:

• Any condition that, in the opinion of the investigator might interfere with the implantation of affect the patients well-being
• Sepsis (local or generalized) or acute infections
• Allergy to anti-platelet, anti-coagulant or ani-thrombotic therapy
• Allergy to nickel and/or Titanium and or nickel-titanium-based matierials

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety in the 1 year following implantation	Percentage of patients with at least one SADE	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Placement	Device in situ in the 3 years following implantation	3 years
Left-Right shunt through AFR device	Evidence of left to right shunt through the AFR device in the 3 years following implantation	3 years
NYHA status		3 years
Change in Quality of life	Change in quality of life as assessed by KCCQ	3 years

Collaborators and Investigators

• Sponsor: Occlutech International AB

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: May 25, 2020
• First Submitted That Met QC Criteria: May 25, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Occ2020_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No