An interventional study of Penditure™ Left Atrial Appendage (LAA) Exclusion System in Left Atrial Appendage Exclusion, sponsored by Medtronic Cardiac Surgery. Active, not recruiting at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Medtronic Cardiac Surgery · Not applicable, Interventional, and Treatment
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.
Medtronic Cardiac Surgery is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Penditure™ Left Atrial Appendage (LAA) Exclusion System
Device: Penditure™ Left Atrial Appendage (LAA) Exclusion System
Exclusion of the left atrial appendage using the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.
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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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Medtronic Cardiac Surgery