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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04405583
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : November 30, 2022
Sponsor:
Information provided by (Responsible Party):
Occlutech International AB

Brief 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.

Condition or disease Intervention/treatment
Heart Failure 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Multicentre, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech Atrial Flow Regulator in Heart Failure Patients
Actual Study Start Date : October 28, 2020
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • Device: Occlutech Atrial Flow Regulator
    The Occlutech Atrial Flow Regulator is an interatrial shunt device for transcatheter delivery.
    Other Name: Occlutech AFR


Primary Outcome Measures :
  1. Safety in the 1 year following implantation [ Time Frame: 1 year ]
    Percentage of patients with at least one SADE


Secondary Outcome Measures :
  1. Device Placement [ Time Frame: 3 years ]
    Device in situ in the 3 years following implantation

  2. Left-Right shunt through AFR device [ Time Frame: 3 years ]
    Evidence of left to right shunt through the AFR device in the 3 years following implantation

  3. NYHA status [ Time Frame: 3 years ]
  4. Change in Quality of life [ Time Frame: 3 years ]
    Change in quality of life as assessed by KCCQ



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405583


Contacts
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Contact: Gonul Sonmez Utkun +90 542 826 11 95 dl_occlutech_clinical_team_eu-ist@occlutech.com
Contact: Inga-Maria Wefel +49 171 715 85 88 dl_occlutech_clinical_team_eu-ist@occlutech.com

Locations
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France
CHU Besançon Not yet recruiting
Besançon, France
CHU Lyon Recruiting
Lyon, France
CHU Montpellier Recruiting
Montpellier, France
Germany
Clinic Coburg Recruiting
Coburg, Germany
University Clinic Recruiting
Cologne, Germany
Helios Clinic Erfurt Active, not recruiting
Erfurt, Germany
Cardiologicum Hamburg Active, not recruiting
Hamburg, Germany
WKK Heide Recruiting
Heide, Germany
University Clinic Jena Recruiting
Jena, Germany
Hospital Osnabrueck Recruiting
Osnabrück, Germany
Elbe Clinic Stade Recruiting
Stade, Germany
University Clinic Tübingen Active, not recruiting
Tübingen, Germany
Sponsors and Collaborators
Occlutech International AB
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Responsible Party: Occlutech International AB
ClinicalTrials.gov Identifier: NCT04405583    
Other Study ID Numbers: Occ2020_01
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: November 30, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases