The purpose of this study is to collect post-market clinical evidence on performance and clinical outcomes of the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.
Multi center, single-arm, nonrandomized, interventional, unblinded, post-market study. Up to 150 subjects will be enrolled and implanted with the Penditure™ Left Atrial Appendage (LAA) Exclusion Clip at up to 25 sites in the United States. Subjects will be followed at 30 days, 3 months, 12-months and annually for 36-months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
198
Exclusion of the left atrial appendage using the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rate of successful exclusion of the left atrial appendage (LAA) from the heart
The primary efficacy endpoint is the rate of successful exclusion of the left atrial appendage (LAA) from the heart defined as the absence of residual communication (≤ 3 mm residual contrast communication) between the left atrium (LA) and the left atrial appendage (LAA). For those successfully placed devices, exclusion will be confirmed at 3 months as demonstrated by multi-detector computed tomography (MDCT) scan.
Time frame: 3 months post procedure
Rate of device related adverse events
The primary safety endpoint is the composite rate of device-related serious adverse cardiac events at 30-days post-procedure.
Time frame: 30 days post procedure
Rate of successful placement of the Penditure™ left atrial appendage (LAA) Exclusion System
The secondary efficacy endpoint is defined as the rate of successful placement of the Penditure™ LAA Exclusion System defined as \< 10 mm of residual stump proximal to the clip at the time of the procedure (measured by intraoperative TEE with doppler) without tissue damage requiring intervention.
Time frame: At the time of procedure
Rate of device related adverse events
The secondary safety endpoint is defined as the composite device-related serious adverse cardiac event rate at 12-months and annually through 36 months.
Time frame: At 1 year, 2 year, and 3 years post procedure
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