NCT04405583

Brief Summary

This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
7 countries

27 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Oct 2020Oct 2027

First Submitted

Initial submission to the registry

May 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

October 28, 2020

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

6.7 years

First QC Date

May 25, 2020

Last Update Submit

January 27, 2026

Conditions

Heart Failure

Keywords

Occlutech AFRAtrial Flow RegulatorInteratrial shunt deviceHeart failureHFrEFHFpEFLeft-to-right shuntBalloon atrial septostomyMACNEDevice embolizationAFRAFR Registry

Outcome Measures

Primary Outcomes (1)

  • Rate of subjects with at least one Major Adverse Cardiovascular and Neurologic Events (MACNE) in the 1 year following implantation.

    MACNE includes all-cause mortality, stroke, systemic thromboembolism, open cardiac surgery or major endovascular repair, and major bleeding (BARC 3-5).

    1 year

Secondary Outcomes (13)

  • Rate of subjects with at least one SAE/ (S)ADE at 12 months, 24 months and 36 months after implantation.

    3 years

  • Cardiovascular Events at 12 months, 24 months and 36 months after implantation.

    3 years

  • Device performance at 12 months, 24 months and 36 months after implantation.

    3 years

  • NYHA class status in comparison to Baseline.

    3 years

  • Subject QoL assessment using the KCCQ in comparison to Baseline.

    3 years

  • +8 more secondary outcomes

Interventions

Occlutech Atrial Flow RegulatorDEVICE

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

Also known as: Occlutech AFR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

150 Heart Failure patients with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF), age ≥18 years, who gave their signed and dated informed consent will be included in the study analysis.

You may qualify if:

  • Written, informed consent
  • Age ≥18 years
  • Presence of chronic symptomatic HF (NYHA class ≥ 2)
  • Left Atrial Pressure (LAP) \> Right Atrial Pressure (RAP); with a gradient equal or more than 5 mmHg\*
  • LVEF ≥ 15%. If LVEF is \>40% (HFpEF), BMI corrected\*\* NT-pro-BNP must be elevated ≥ 125 pg/mL. (BNP \>35 pg/mL) or ≥ 365pg/ml (BNP \> 105 pg/mL) for patients with atrial fibrillation (AF)
  • Stable guideline directed treatment according to latest applicable ESC guidelines for respective HF phenotypes for at least 1 months prior to informed consent

You may not qualify if:

  • Life expectancy \< 1 year, or advanced heart failure defined as ACC/AHA Stage D heart failure, or listed for heart transplantation at time of baseline visit
  • Evidence of right heart failure defined (by ECHO) as:
  • Severe Right Ventricular Dysfunction (TAPSE \< 14 mm)
  • Severe Right Ventricular Dilatation (RV volume ≥ LV volume)
  • Severe pulmonary hypertension (PASP \> 60 mm Hg)
  • Echocardiographic evidence of intra-cardia mass, thrombus or vegetation
  • Uncontrolled hypertension, Systolic Blood Pressure of \>160 mmHg or Diastolic Blood Pressure ≥ 100mmHg, despite medical therapy at the time of screening visit.
  • Uncontrolled atrial fibrillation with resting heart rate \>110bpm, despite medical therapy
  • Documented history of specific cardiomyopathy (obstructive hypertrophic, restrictive, infiltrative) or pericardial disease
  • Congenital heart defect that interferes with placement of the device, at the discretion of the Investigator.
  • Previous interventional or surgical atrial septal defect (ASD) or patent foramen ovale (PFO) closure interfering with the placement of the device
  • Current atrial septal defect, or anatomical anomaly (including \> 10 mm atrial septal thickness or atrial septal aneurysm) on ECHO that precludes implantation of the device across the fossa ovalis (FO) of the interatrial septum
  • Clinically significant valvular heart disease:
  • regurgitation grade ≥3+ or
  • severe stenosis of mitral or tricuspid valves, or
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

CHU Besançon

Besançon, France

RECRUITING

CHU Bourdeaux

Bourdeaux, France

RECRUITING

CHU Lyon

Lyon, France

RECRUITING

CHU Montpellier

Montpellier, France

RECRUITING

Centre Hospitalier Universitaire Rangueil

Toulouse, France

NOT YET RECRUITING

Knappschaftskrankenhaus Bottrop GmbH

Bottrop, Germany

NOT YET RECRUITING

Clinic Coburg

Coburg, Germany

RECRUITING

University Clinic

Cologne, Germany

RECRUITING

Helios Clinic Erfurt

Erfurt, Germany

ACTIVE NOT RECRUITING

Cardiologicum Hamburg

Hamburg, Germany

TERMINATED

WKK Heide

Heide, Germany

RECRUITING

University Clinic Jena

Jena, Germany

RECRUITING

Hospital Osnabrueck

Osnabrück, Germany

RECRUITING

Elbe Clinic Stade

Stade, Germany

RECRUITING

University Clinic Tübingen

Tübingen, Germany

ACTIVE NOT RECRUITING

Hippokration Hospital Athens

Athens, Greece

RECRUITING

Mitera Hospital Athens

Athens, Greece

NOT YET RECRUITING

Onassis Cardiac Surgery Center

Athens, Greece

NOT YET RECRUITING

European Interbalkan Medical Center

Thessaloniki, Greece

RECRUITING

Hippokration Hospital of Thessaloniki

Thessaloniki, Greece

RECRUITING

Careggi University Hospital

Florence, Italy

NOT YET RECRUITING

Centro Cardiologico Monzino

Milan, Italy

RECRUITING

Hospital de Santa Cruz

Carnaxide, Portugal

NOT YET RECRUITING

Hospital de Santa Marta

Lisbon, Portugal

NOT YET RECRUITING

Dedinje Cardiovascular Institute

Dedinje, Serbia

NOT YET RECRUITING

Rabta Hospital

Tunis, Tunisia

RECRUITING

The Military Hospital of Tunis

Tunis, Tunisia

RECRUITING

Ankara Etlik Şehir Hastanesi

Ankara, Turkey (Türkiye)

RECRUITING

Güven Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Hacettepe Üniversitesi Tip Fakültesi

Ankara, Turkey (Türkiye)

RECRUITING

Firat University Hospital

Elâzığ, Turkey (Türkiye)

RECRUITING

Binali Yildirim University Mengücek Gazi Training and Resear

Erzincan, Turkey (Türkiye)

RECRUITING

Bezmialem Uni. Hospital

Fatih, Turkey (Türkiye)

RECRUITING

İzmir City Hospital

Izmir, Turkey (Türkiye)

RECRUITING

Kocaeli Üniversitesi Araştirma Ve Uygulama Hastanesi

Kocaeli, Turkey (Türkiye)

RECRUITING

Namik Kemal University Hospital

Tekirdağ, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Gönül Sonmez Utkun

CONTACT

+90 542 826 11 95dl_occlutech_clinical_team_eu-ist@occlutech.com

Sankoung Minte

CONTACT

+337 68 20 44 58sankoung.minte@keena-lifesciences.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2020

First Posted

May 28, 2020

Study Start

October 28, 2020

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations

IT(2)GR(5)FR(5)SE(1)TU(2)PT(2)DE(10)