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The CLAAS® device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the CLAAS device or the WATCHMAN or Amulet™ devices and will be followed for 5 years after device implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLAAS | Experimental | Transcatheter left atrial occluder |
|
| WATCHMAN / Amulet | Active Comparator | Transcatheter left atrial occluder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLAAS | Device | CLAAS |
| |
| WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure-related complications, all-cause death, major bleeding | The primary safety endpoint is a composite of 1) major procedure-related complications including a) cardiac perforation, b) pericardial effusion requiring drainage, c) ischemic stroke, d) device embolization, and e) major vascular complications, or 2) major bleeding, or 3) all-cause death | 12 months |
| Ischemic stroke and systemic embolism | The primary effectiveness endpoint is a composite of ischemic stroke and systemic embolism through 18 months. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure-related complications, all-cause death, major bleeding | All elements of the Primary Safety Endpoint will be reported descriptively for all subjects through 5 years: a composite of 1) major procedure-related complications including a) cardiac perforation, b) pericardial effusion requiring drainage, c) ischemic stroke, d) device embolization, and e) major vascular complications, or 2) major bleeding, or 3) all-cause death |
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Inclusion Criteria:
Exclusion Criteria:
Echo exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Gallagher | Contact | 952-270-8356 | sgallagher@conformalmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| William Gray, M.D. | Lankenau Heart Institute | Principal Investigator |
| Shephal Doshi, M.D. | Pacific Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grandview Medical Center | Recruiting | Birmingham | Alabama | 35243 | United States |
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| Device |
WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder |
|
| 5 years |
| Device Success | A secondary performance and efficacy endpoint is Device Success, defined as LAAO device deployed and implanted in correct position | Procedure |
| Technical success | A secondary performance and efficacy endpoint is Technical Success, defined as Device Success, complete closure or peri-device residual leak ≤5 mm in width on TEE, as evaluated by independent imaging core lab without device-related complications [evaluated post-procedure]. | 45 days |
| Procedure success | A secondary performance and efficacy endpoint is Procedure Success, defined as Technical Success without in-hospital major procedure-related complications (excluding minor device embolization) evaluated at hospitalization or at 7 days whichever is first. | 7 Days |
| Embolic Events | A secondary performance and efficacy endpoint is Embolic Events, defined as ischemic stroke as defined by NeuroARC (29) and systemic thromboembolism characterized as any thromboemboli in the arterial system. | 12 Months, 18 Months |
| Closure Success | A secondary performance and efficacy endpoint is Closure Success at 12 months based upon each of the following criteria: a) demonstration of peri-device leak \ | 12 months |
| Banner University Medical Center Phoenix | Recruiting | Phoenix | Arizona | 85006 | United States |
|
| Abrazo Arizona Heart Hospital | Active, not recruiting | Phoenix | Arizona | 85016 | United States |
| Arizona Heart Arrhythmia Associates | Recruiting | Phoenix | Arizona | 85018 | United States |
|
| HonorHealth | Recruiting | Scottsdale | Arizona | 85258 | United States |
|
| Pima Heart & Vascular | Recruiting | Tucson | Arizona | 85719 | United States |
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| St. Bernard's Medical Center | Recruiting | Jonesboro | Arkansas | 72401 | United States |
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| Loma Linda University Health | Recruiting | Loma Linda | California | 92354 | United States |
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| Huntington Hospital | Recruiting | Pasadena | California | 91105 | United States |
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| Pacific Heart Institute | Recruiting | Santa Monica | California | 90405 | United States |
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| Community Memorial Hospital Ventura | Recruiting | Ventura | California | 93003 | United States |
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| South Denver Cardiology Associates | Recruiting | Littleton | Colorado | 80120 | United States |
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| Hartford Health Care St. Vincent's Medical Center | Recruiting | Bridgeport | Connecticut | 06606 | United States |
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| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| Ascension St. Vincent's Jacksonville | Active, not recruiting | Jacksonville | Florida | 32204 | United States |
| Largo Medical Center | Recruiting | Largo | Florida | 33770 | United States |
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| Baptist Hospital of Miami | Recruiting | Miami | Florida | 33176 | United States |
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| AdventHealth Orlando | Recruiting | Orlando | Florida | 32803 | United States |
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| Baptist Health Care - Pensacola | Recruiting | Pensacola | Florida | 32503 | United States |
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| Sarasota Memorial Health Care System | Recruiting | Sarasota | Florida | 34239 | United States |
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| AdventHealth Tampa | Recruiting | Tampa | Florida | 33613 | United States |
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| USF - Tampa General Hospital | Recruiting | Tampa | Florida | 33620 | United States |
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| Piedmont Health Institute | Recruiting | Atlanta | Georgia | 30309 | United States |
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| Emory University | Recruiting | Atlanta | Georgia | 30342 | United States |
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| Northside Hospital, Inc | Recruiting | Atlanta | Georgia | 30342 | United States |
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| WellStar Kennestone Hospital | Recruiting | Marietta | Georgia | 30062 | United States |
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| Midwest Cardiovascular Institute | Recruiting | Naperville | Illinois | 60540 | United States |
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| Ascension St. Vincent - Carmel, IN | Active, not recruiting | Indianapolis | Indiana | 46260 | United States |
| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
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| Terrebone - Cardiovascular Institute of the South | Recruiting | Houma | Louisiana | 70360 | United States |
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| Medstar Union Memorial Hospital | Recruiting | Baltimore | Maryland | 21218 | United States |
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| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Lahey Hospital & Medical Centeer | Recruiting | Burlington | Massachusetts | 01805 | United States |
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| Baystate Medical Center | Recruiting | Springfield | Massachusetts | 01199 | United States |
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| Henry Ford St. John Hospital | Recruiting | Detroit | Michigan | 48236 | United States |
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| Corewell Health | Active, not recruiting | Grand Rapids | Michigan | 49503 | United States |
| Henry Ford Providence Southfield Hospital | Recruiting | Southfield | Michigan | 48075 | United States |
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| M Health Fairview St. John's Hospital | Recruiting | Maplewood | Minnesota | 55109 | United States |
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| CentraCare Heart and Vascular Center | Active, not recruiting | Saint Cloud | Minnesota | 56303 | United States |
| North Mississippi Medical Center | Recruiting | Tupelo | Mississippi | 38801 | United States |
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| Saint Luke's Hospital of Kansas City | Recruiting | Kansas City | Missouri | 64111 | United States |
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| Kansas City Cardiac Arrhythmia Research, LLC | Recruiting | Overland | Missouri | 66211 | United States |
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| CHI Health / CommonSpirit Research Institute | Active, not recruiting | Omaha | Nebraska | 68124 | United States |
| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
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| Catholic Medical Center | Active, not recruiting | Manchester | New Hampshire | 03102 | United States |
| Deborah Heart and Lung | Recruiting | Browns Mills | New Jersey | 08015 | United States |
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| Hackensack University Medical Center | Active, not recruiting | Hackensack | New Jersey | 07601 | United States |
| Cooper University - Heart House | Recruiting | Haddon Heights | New Jersey | 08104 | United States |
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| New Mexico Heart Institute | Recruiting | Albuquerque | New Mexico | 87102 | United States |
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| Albany Medical Center / Capital Cardiology Associates | Recruiting | Albany | New York | 12208 | United States |
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| University of Buffalo / Kaleida Health | Recruiting | Buffalo | New York | 14203 | United States |
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| Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
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| Mission Hospital | Recruiting | Asheville | North Carolina | 28801 | United States |
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| TriHealth | Recruiting | Cincinnati | Ohio | 45242 | United States |
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| Ohio Health Research Institute | Active, not recruiting | Columbus | Ohio | 43214 | United States |
| ProMedica Toledo Hospital | Recruiting | Toledo | Ohio | 43606 | United States |
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| UPMC Harrisburg | Recruiting | Mechanicsburg | Pennsylvania | 17050 | United States |
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| Lankenau Heart Institute | Recruiting | Wynnewood | Pennsylvania | 19096 | United States |
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| Lifespan Health System | Active, not recruiting | Providence | Rhode Island | 02903 | United States |
| Prisma Health | Recruiting | Columbia | South Carolina | 29203 | United States |
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| HCA Grand Strand | Recruiting | Myrtle Beach | South Carolina | 29572 | United States |
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| Trident Medical Center | Recruiting | North Charleston | South Carolina | 29406 | United States |
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| Lexington Medical Center | Recruiting | West Columbia | South Carolina | 29169 | United States |
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| Erlanger Health System | Active, not recruiting | Chattanooga | Tennessee | 37403 | United States |
| Tennova Healthcare - Turkey Creek Medical Center | Recruiting | Knoxville | Tennessee | 37934 | United States |
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Houston Methodist | Recruiting | Houston | Texas | 77030 | United States |
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| Memorial Hermann Memorial City Medical Center | Recruiting | Houston | Texas | 77094 | United States |
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| Baylor Scott & White Research Institute | Recruiting | Plano | Texas | 75093 | United States |
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| CHRISTUS Health | Recruiting | Tyler | Texas | 75701 | United States |
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| Sentara Norfolk | Active, not recruiting | Norfolk | Virginia | 23507 | United States |
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23219 | United States |
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| Chippenham Hospital | Recruiting | Richmond | Virginia | 23225 | United States |
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| Carilion Clinic | Recruiting | Roanoke | Virginia | 24014 | United States |
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| Virginia Mason Medical Center | Recruiting | Seattle | Washington | 98101 | United States |
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| West Virginia University | Recruiting | Morgantown | West Virginia | 26506 | United States |
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| Bellin Health | Recruiting | Green Bay | Wisconsin | 54301 | United States |
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| Nemocnice Na Homolce | Active, not recruiting | Prague | 150 00 | Czechia |
| CHU de Bordeaux | Recruiting | Bordeaux | 33604 | France |
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| CHU La Timone, Marseille | Recruiting | Marseille | 13005 | France |
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| Institut Cardiovasculaire Paris Sud | Recruiting | Massy | 91300 | France |
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| CHU de Toulouse | Recruiting | Toulouse | 31059 | France |
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| Clinique Pasteur, Toulouse | Recruiting | Toulouse | 31076 | France |
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| Chapidze Heart Disease Center | Active, not recruiting | Tbilisi | Georgia |
| Israeli-Georgian Medical Research Clinic Helsicore | Active, not recruiting | Tbilisi | Georgia |
| Tbilisi Heart and Vascular Clinic | Active, not recruiting | Tbilisi | Georgia |
| Tbilisi Heart Center | Active, not recruiting | Tbilisi | Georgia |
| Elisabeth Krankenhaus | Recruiting | Essen | 45138 | Germany |
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| Cardiovasculäres Centrum Frankfurt | Recruiting | Frankfurt | 60389 | Germany |
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| Asklepios Klinik-Altona | Recruiting | Hamburg | 22763 | Germany |
|
| Republican Specialized Center for Surgery named after V. Vakhidov | Active, not recruiting | Chilanzar | Tashkent | 100115 | Uzbekistan |
| AKFA Medline | Active, not recruiting | Olmazor | Tashkent | 100211 | Uzbekistan |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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