Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
AtriClip LAA Exclusion System: LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
Study summary
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.
Eligibility
Primary outcome measure(s)
- Primary Effectiveness Endpoint — Common termination point (median follow-up for 5 years)
Time to the first occurrence of ischemic stroke or systemic arterial embolism as adjudicated by the Clinical Events Committee (CEC), or any procedure wherein the LAA was excluded, occluded, or amputated following the index procedure. - Primary Safety Endpoint — 30 days post index procedure
Occurrence of at least one of the following events assessed through 30 days post index procedure: * Pericardial effusion requiring percutaneous or surgical treatment * Major bleeding attributable to index surgical procedure * Deep sternal wound infection * Myocardial infarction
Trial sites (138)
| Facility | City | Region | Status |
|---|---|---|---|
| Heart Center Research / Huntsville Hospital | Huntsville | Alabama | |
| HonorHealth Shea Scottsdale Healthcare | Scottsdale | Arizona | |
| St. Bernard's Heart & Vascular | Jonesboro | Arkansas | |
| CHI St. Vincent | Little Rock | Arkansas | |
| Arkansas Heart Hospital | Little Rock | Arkansas | |
| Memorial Care Long Beach Medical Center | Long Beach | California | |
| Keck Medical Center of USC | Los Angeles | California | |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | |
| Sutter Sacramento Hospital | Sacramento | California | |
| Stanford University | Stanford | California | |
| University of Colorado | Boulder | Colorado | |
| Hartford Hospital | Hartford | Connecticut | |
| Christiana Care Health Services | Newark | Delaware | |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | |
| HCA Florida JFK Hospital | Atlantis | Florida | |
| HealthPark Medical Center | Fort Myers | Florida | |
| University of Florida Hospital | Gainesville | Florida | |
| Memorial Regional Hospital | Hollywood | Florida | |
| Baptist Health Jacksonville | Jacksonville | Florida | |
| Baptist Health South Florida | Miami | Florida | |
| Orlando Regional Medical Center | Orlando | Florida | |
| Sarasota Memorial Hospital | Sarasota | Florida | |
| Tampa General Hospital | Tampa | Florida | |
| Baycare Health System | Tampa | Florida | |
| Emory University Hospital | Atlanta | Georgia | |
| Piedmont Hospital | Atlanta | Georgia | |
| Wellstar - Kennestone | Marietta | Georgia | |
| St. Luke's Regional Medical Center | Boise | Idaho | |
| Portneuf Medical Center | Idaho Falls | Idaho | |
| Northwestern Memorial Hospital | Chicago | Illinois | |
| Loyola University Medical Center | Maywood | Illinois | |
| Memorial Hospital (SIU Medicine) | Springfield | Illinois | |
| Ascension St. Vincent | Carmel | Indiana | |
| Franciscan | Indianapolis | Indiana | |
| Mercy Medical Center | Des Moines | Iowa | |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | |
| St. Luke's Hospital | Kansas City | Kansas | |
| Kansas University Medical Center | Kansas City | Kansas | |
| Baptist Health | Lexington | Kentucky | |
| University of Kentucky | Lexington | Kentucky |
+ 98 more sites — see the full list on the official registry below.
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05478304 on ClinicalTrials.gov ↗ ← All trials in Spain