Actively Recruiting
The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients
Led by Occlutech International AB · Updated on 2026-01-29
150
Participants Needed
36
Research Sites
361 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.
CONDITIONS
Official Title
The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Age 18 years or older
- Chronic symptomatic heart failure with NYHA class 2 or higher
- Left atrial pressure greater than right atrial pressure with a gradient of at least 5 mmHg
- Left ventricular ejection fraction of 15% or higher; if above 40%, elevated NT-pro-BNP levels adjusted for body mass index
- Stable guideline-directed heart failure treatment for at least 1 month before consent
You will not qualify if you...
- Life expectancy less than 1 year or advanced heart failure (ACC/AHA Stage D) or listed for heart transplant
- Severe right ventricular dysfunction or dilatation or severe pulmonary hypertension
- Echocardiographic evidence of intra-cardiac mass, thrombus, or vegetation
- Uncontrolled hypertension with systolic blood pressure above 160 mmHg or diastolic above 100 mmHg despite therapy
- Uncontrolled atrial fibrillation with resting heart rate over 110 bpm despite therapy
- History of specific cardiomyopathies or pericardial disease
- Congenital heart defect interfering with device placement
- Previous atrial septal defect or patent foramen ovale closure interfering with device placement
- Current atrial septal defect or anatomical anomalies preventing device implantation
- Significant valvular heart disease (regurgitation grade 3 or higher, severe stenosis)
- Prior diagnosis of primary pulmonary hypertension
- Severe COPD requiring steroids or oxygen
- Stroke, TIA, DVT, pulmonary embolism within 6 months or prior stroke with neurologic deficit
- Recent myocardial infarction or coronary intervention within 2 months
- ICD or right-sided pacemaker placed within 2 months
- Significant coagulation disorders
- Sepsis or acute infection requiring antibiotics within 2 months
- Chronic kidney disease requiring dialysis
- Allergy to device materials or related therapies if not manageable
- Participation in another interfering clinical trial
- Other significant comorbidities making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 36 locations
1
CHU Besançon
Besançon, France
Actively Recruiting
2
CHU Bourdeaux
Bourdeaux, France
Actively Recruiting
3
CHU Lyon
Lyon, France
Actively Recruiting
4
CHU Montpellier
Montpellier, France
Actively Recruiting
5
Centre Hospitalier Universitaire Rangueil
Toulouse, France
Not Yet Recruiting
6
Knappschaftskrankenhaus Bottrop GmbH
Bottrop, Germany
Not Yet Recruiting
7
Clinic Coburg
Coburg, Germany
Actively Recruiting
8
University Clinic
Cologne, Germany
Actively Recruiting
9
Helios Clinic Erfurt
Erfurt, Germany
Active, Not Recruiting
10
Cardiologicum Hamburg
Hamburg, Germany
Terminated
11
WKK Heide
Heide, Germany
Actively Recruiting
12
University Clinic Jena
Jena, Germany
Actively Recruiting
13
Hospital Osnabrueck
Osnabrück, Germany
Actively Recruiting
14
Elbe Clinic Stade
Stade, Germany
Actively Recruiting
15
University Clinic Tübingen
Tübingen, Germany
Active, Not Recruiting
16
Hippokration Hospital Athens
Athens, Greece
Actively Recruiting
17
Mitera Hospital Athens
Athens, Greece
Not Yet Recruiting
18
Onassis Cardiac Surgery Center
Athens, Greece
Not Yet Recruiting
19
European Interbalkan Medical Center
Thessaloniki, Greece
Actively Recruiting
20
Hippokration Hospital of Thessaloniki
Thessaloniki, Greece
Actively Recruiting
21
Careggi University Hospital
Florence, Italy
Not Yet Recruiting
22
Centro Cardiologico Monzino
Milan, Italy
Actively Recruiting
23
Hospital de Santa Cruz
Carnaxide, Portugal
Not Yet Recruiting
24
Hospital de Santa Marta
Lisbon, Portugal
Not Yet Recruiting
25
Dedinje Cardiovascular Institute
Dedinje, Serbia
Not Yet Recruiting
26
Rabta Hospital
Tunis, Tunisia
Actively Recruiting
27
The Military Hospital of Tunis
Tunis, Tunisia
Actively Recruiting
28
Ankara Etlik Şehir Hastanesi
Ankara, Turkey (Türkiye)
Actively Recruiting
29
Güven Hospital
Ankara, Turkey (Türkiye)
Actively Recruiting
30
Hacettepe Üniversitesi Tip Fakültesi
Ankara, Turkey (Türkiye)
Actively Recruiting
31
Firat University Hospital
Elâzığ, Turkey (Türkiye)
Actively Recruiting
32
Binali Yildirim University Mengücek Gazi Training and Resear
Erzincan, Turkey (Türkiye)
Actively Recruiting
33
Bezmialem Uni. Hospital
Fatih, Turkey (Türkiye)
Actively Recruiting
34
İzmir City Hospital
Izmir, Turkey (Türkiye)
Actively Recruiting
35
Kocaeli Üniversitesi Araştirma Ve Uygulama Hastanesi
Kocaeli, Turkey (Türkiye)
Actively Recruiting
36
Namik Kemal University Hospital
Tekirdağ, Turkey (Türkiye)
Actively Recruiting
Research Team
G
Gönül Sonmez Utkun
CONTACT
S
Sankoung Minte
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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