Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT00962702
Status:
UNKNOWN
Last Update Posted:
2009-08-20
First Post:
2009-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exclusion of the Left Atrial Appendage (LAA) With the LAAx, Inc. TigerPaw System
Sponsor:
LAAx, Inc.
Organization:
Study Overview
Official Title:
Exclusion of the Left Atrial Appendage With the LAAx, Inc., TigerPaw™ System During Elective, Non-Endoscopic Cardiac Surgery Procedures
Status:
UNKNOWN
Status Verified Date:
2009-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The dual primary safety and effectiveness outcomes for the use of The TigerPaw System include the rate of device related adverse and serious adverse events and the extent of complete exclusion of the LAA with minimal residual cavity.
Detailed Description:
The primary safety outcome is the rate of device related adverse and serious adverse events assessed peri-operatively, and at 30 and 90 days post procedure. The primary effectiveness outcome is the percentage of patients with complete exclusion of the left atrial appendage assessed peri-operatively (visually), and at 90 days post procedure via transesophageal echocardiography (TEE).
Transesophageal echocardiography will be performed intra-operatively and again at 90 days post procedure. Intra-operative and follow-up TEE examinations will be read centrally at a core laboratory. Any Doppler flow across the Fastener into the excluded portion of the appendage will also be considered a failure of exclusion. The presence or absence of LAA and/or LA thrombus will be evaluated. Patients will also be evaluated for other potential sources of embolism, including aortic atheroma, patent foramen ovale, or other intracardiac shunts.
Data collection will be completed at baseline, at the time of open cardiac surgery procedure and throughout the perioperative hospitalization. Patients will be evaluated at 30 days post surgery and at 90 days post surgery.
Transesophageal echocardiography will be performed intra-operatively and again at 90 days post procedure. Intra-operative and follow-up TEE examinations will be read centrally at a core laboratory. Any Doppler flow across the Fastener into the excluded portion of the appendage will also be considered a failure of exclusion. The presence or absence of LAA and/or LA thrombus will be evaluated. Patients will also be evaluated for other potential sources of embolism, including aortic atheroma, patent foramen ovale, or other intracardiac shunts.
Data collection will be completed at baseline, at the time of open cardiac surgery procedure and throughout the perioperative hospitalization. Patients will be evaluated at 30 days post surgery and at 90 days post surgery.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: