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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Penditure⢠Left Atrial Appendage (LAA) Exclusion System | Experimental | Penditure⢠Left Atrial Appendage (LAA) Exclusion System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penditure⢠Left Atrial Appendage (LAA) Exclusion System | Device | Exclusion of the left atrial appendage using the Penditure⢠Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 30 days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the time of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | United States | ||
| Northwestern Memorial Hospital |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 19, 2025 | Apr 7, 2026 |
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| 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. | At 1 year, 2 year, and 3 years post procedure |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Ascension St. Vincent Heart Center | Carmel | Indiana | 46290 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Corewell Health | Grand Rapids | Michigan | 49503 | United States |
| Mayo Clinic Saint Marys Campus | Rochester | Minnesota | 55905 | United States |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Saint Joseph's Hospital Health Center | Syracuse | New York | 13203 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| ProMedica Toledo Hospital | Toledo | Ohio | 43606 | United States |
| UPMC Pinnacle Harrisburg Campus | Harrisburg | Pennsylvania | 17101 | United States |
| University of Pittsburgh Medical Center UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | United States |
| Lankenau Institute for Medical Research | Wynnewood | Pennsylvania | 19096 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Swedish Medical Center Cherry Hill | Seattle | Washington | 98112 | United States |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 18, 2025 | Apr 7, 2026 | SAP_001.pdf |