The aim of the study is to assess invasive and non-invasive parameters that may predict clinical improvement in patients with congestive heart failure after implantation of Occlutech® Atrial flow regulator (AFR) device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Atrial septostomy followed by implantation of AFR.
Kashubian Cardiovascular Center
Wejherowo, Poland
RECRUITINGClinical improvement
Increase in 6 minutes walk test distance
Time frame: 12 months
Clinical improvement II
Reduction in New York Heart Association (NYHA) class
Time frame: 12 months
Device related adverse event
Device migration, embolization, device related thrombus, shunt occlusion, need for device removal
Time frame: 12 months
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