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

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

Recruiting
18 years and older
All
Phase N/A
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Overview

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.

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

Study details
    Heart Failure

NCT04405583

Occlutech International AB

27 January 2024

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