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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04405583
• Other study ID #: Occ2020_01
• Status: Recruiting
• Start date: October 28, 2020
• Est. completion date: October 2027

Study information

• Verified date: November 2023
• Source: Occlutech International AB
• Contact: Gonul Sonmez Utkun
• Phone: +90 542 826 11 95
• Email: dl_occlutech_clinical_team_eu-ist[@]occlutech.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2027
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Occlutech Atrial Flow Regulator
The Occlutech Atrial Flow Regulator is an interatrial shunt device for transcatheter delivery.

Locations

Country	Name	City	State
France	CHU Besançon	Besançon
France	CHU Lyon	Lyon
France	CHU Montpellier	Montpellier
Germany	Knappschaftskrankenhaus Bottrop GmbH	Bottrop
Germany	Clinic Coburg	Coburg
Germany	University Clinic	Cologne
Germany	Helios Clinic Erfurt	Erfurt
Germany	Cardiologicum Hamburg	Hamburg
Germany	WKK Heide	Heide
Germany	University Clinic Jena	Jena
Germany	Clinic Osnabrück	Osnabrück
Germany	Hospital Osnabrueck	Osnabrück
Germany	Elbe Clinic Stade	Stade
Germany	University Clinic Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Occlutech International AB

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety in the 1 year following implantation	Percentage of patients with at least one SADE	1 year
Secondary	Device Placement	Device in situ in the 3 years following implantation	3 years
Secondary	Left-Right shunt through AFR device	Evidence of left to right shunt through the AFR device in the 3 years following implantation	3 years
Secondary	NYHA status		3 years
Secondary	Change in Quality of life	Change in quality of life as assessed by KCCQ	3 years