This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.
This is a prospective, multicentre, international, follow-up registry to monitor the safety and the performance of the Occlutech AFR device in patients with Heart Failure, to identify unknown side effects and to assess the indications and contraindications for an AFR treatment. Efficacy and safety of implanted device(s) will be evaluated by vital signs, laboratory test, quality of life questionnaire, ECG, and echocardiography data over a follow-up period of 36 month after implantation. Patients will be treated according to the instruction-for-use of the device and according to clinical routine. Procedures will be performed at sites having appropriate laboratory support and adequately trained imaging personnel. Procedures will be performed by physicians with experience in a wide range of interventional cardiology and structural heart disease.
Study Type
OBSERVATIONAL
Enrollment
150
The Occlutech Atrial Flow Regulator is an interatrial shunt device for transcatheter delivery.
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).
Time frame: 1 year
Rate of subjects with at least one SAE/ (S)ADE at 12 months, 24 months and 36 months after implantation.
Time frame: 3 years
Cardiovascular Events at 12 months, 24 months and 36 months after implantation.
Heart Failure hospitalization rate; Cardiovascular mortality; Unplanned HF admission or treatment intensification.
Time frame: 3 years
Device performance at 12 months, 24 months and 36 months after implantation.
Device placed in situ as assessed by the investigator; Patency: evidence of LEFT TO RIGHT shunt through the AFR device; Implant embolization and clinically significant device migration.
Time frame: 3 years
NYHA class status in comparison to Baseline.
Time frame: 3 years
Subject QoL assessment using the KCCQ in comparison to Baseline.
Time frame: 3 years
6 Minute Walk Test distance [m] in comparison to Baseline.
Time frame: 3 years
Heart rhythm in comparison to Baseline
Time frame: 3 years
Left Ventricular (LV), Right Ventricular (RV) and Left Atrial (LA) structure and function including strain derived indices in comparison to Baseline.
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CHU Besançon
Besançon, France
RECRUITINGCHU Bourdeaux
Bourdeaux, France
RECRUITINGCHU Lyon
Lyon, France
RECRUITINGCHU Montpellier
Montpellier, France
RECRUITINGCentre Hospitalier Universitaire Rangueil
Toulouse, France
NOT_YET_RECRUITINGKnappschaftskrankenhaus Bottrop GmbH
Bottrop, Germany
NOT_YET_RECRUITINGClinic Coburg
Coburg, Germany
RECRUITINGUniversity Clinic
Cologne, Germany
RECRUITINGHelios Clinic Erfurt
Erfurt, Germany
ACTIVE_NOT_RECRUITINGCardiologicum Hamburg
Hamburg, Germany
TERMINATED...and 26 more locations
Time frame: 3 years
Left Ventricular Ejection Fraction (LVEF) in comparison to Baseline.
Time frame: 3 years
Tricuspid Annular Plane Systolic Excursion (TAPSE) in comparison to Baseline.
Time frame: 3 years
Laboratory variables
Laboratory variables, including changes from baseline in: eGRF, NT-Pro-BNP \[pg/ml\]
Time frame: 3 years
Changes in heart failure related medication
reduction/increase of daily dose \[%\]
Time frame: 3 years
Relationship between pacemaker therapy and intra atrial shunt therapy
Time frame: 3 years