The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Aarhus University Hospital, Skejby
Aarhus, Denmark
Kerckhoff-Klinik
Bad Nauheim, Germany
Herz und Gefäß-Klinik
Bad Neustadt an der Saale, Germany
Herzzentrum Leipzig
Leipzig, Germany
Procedural Success
The placement of at least one neochord using the DS1000 System AND a reduction in mitral regurgitation \<= 2+ at the time of the procedure AND maintained MR reduction of \<= 2+ at 30 days
Time frame: 30 days
Procedural Safety
the rate of Major Adverse Events (MAE) defined as a combined endpoint of: death, MI, reoperation for failed surgical repair, non-elective cardiovascular surgery to treat an adverse event, procedural ventilation \> 48 hours, procedure-related transfusion of \> 2 units blood product, stroke, renal failure, deep wound infection, new onset of permanent AF, and septicemia, through 30 days.
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Klinik für Herz-und Gefäßchirurgie
Munich, Germany
San Raffaele
Milan, Italy
Ospedale San Giovanni Battista "Molinette"
Torino, Italy
Vilniaus Universiteto ligonines Santariskiu
Vilnius, Lithuania