The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
The Wesley Hospital
Auchenflower, Queensland, Australia
St Andrews Hospital
Adelaide, South Australia, Australia
Warringal Private Hospital
Heidelberg, Australia
The Mount Hospital
Perth, Australia
Major Adverse Event Rate to 30 Days post-procedure
Major Adverse Events defined as: death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke, renal failure
Time frame: <=30 days post procedure
Mitral regurgitation grade and change from baseline to 30 days
Time frame: <=30 days post procedure
Device Technical Success
At exit from cath lab, alive, with Successful access, delivery and retrieval of the device delivery system, and Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
Time frame: procedural
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ICPS
Massy, France
IRCCS San Donato
Milan, Italy
Pauls Stradins Clinical University Hospital
Riga, Latvia
Brighton and Sussex University Hospitals
Brighton, United Kingdom
St Thomas' Hospital
London, United Kingdom