The Exploratory Study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt System.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Transcatheter treatment of symptomatic left heart failure patients
Rate of Safety Events (MACCREE, Re-Intervention)
Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days.
Time frame: 30 Days
Rate of Device Success
Device is deployed as intended and the delivery system is successfully removed as intended at the time of the patient's exit from the implant procedure room.
Time frame: Day 0
Rate of Procedural Success
Device success with evidence of shunt patency and hospital discharge without the need for additional surgical or percutaneous intervention related to the study device including unacceptable Qp/Qs values.
Time frame: 10 Days post-op
Change in Qp/Qs
Comparison vs baseline of Qp/Qs value at 3 and 6 months
Time frame: Baseline, 3 months, 6 months
Change in PCWP
Comparison vs baseline of PCWP under the same test conditions
Time frame: Baseline, 3 months, 6 months
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