Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| LAM202403 | Other Identifier | Biosense Webster, Inc. | |
| CL-0059 | Other Identifier | Laminar, Inc. |
Not provided
Not provided
Not provided
Potential unwrapping of the LAA post implant with clinically significant leaks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the safety and effectiveness of Laminar Left Atrial Appendage Closure (LAAC) device as compared to the commercially available LAAC devices in participants with non-valvular atrial fibrillation (NVAF) to reduce the risk of stroke (blocked blood vessel or bleeding in brain) and systemic embolism (blockage in a blood vessel harming vital organs).
This prospective, randomized, controlled, multicenter, open-label pivotal clinical study will enroll participants with non-valvular atrial fibrillation who are eligible for short-term anticoagulation therapy but have a rationale to seek non-pharmacologic alternative. Participants will be randomized 1:1 to the Laminar Left Atrial Appendage Closure System or commercially available device (WATCHMANâ„¢ left atrial appendage closure device / Amuletâ„¢ left atrial appendage occluder).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laminar Device | Experimental | Participants will be treated with the Laminar Left Atrial Appendage Closure System. |
|
| Control left atrial appendage closure (LAAC) | Active Comparator | Participants will be treated with a commercially-available LAAC device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Laminar Left Atrial Appendage Closure System | Device | Treatment with the Laminar Left Atrial Appendage Closure System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality | Composite rate of all-cause mortality will be reported. | Up to 12 months |
| Number of Participants With Major Bleeding According to the Bleeding Academic Research Consortium (BARC) Type III or V | The number of participants with major bleeding, according to the BARC type III or V, will be reported. Type III
Type V
| Up to 12 months |
| Number of Participants With Pericardial Effusion Requiring Drainage | Participants with pericardial effusion requiring drainage will be reported. Pericardial effusion is defined as 1) Clinically non-relevant: requiring no intervention, treated pharmacologically and 2) Clinically relevant: treated with therapeutic intervention (pericardiocentesis, surgical intervention, blood transfusion) and/or result in shock or death. | Up to 12 months |
| Number of Participants With Device Embolization | Participants with device embolization will be reported. Device embolization is defined as movement of a medical device to an unintended location within the body with resulting obstruction of an organ or vessel. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Peri-Device Flow | Peri-Device flow is defined as >= 3 mm in width which communicates beyond the device into the body of the left atrial appendage) per transesophageal echocardiogram (TEE) evaluated by independent core laboratory. | Up to 12 Months |
| Rate of Device-Related Thrombosis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Saibal Kar, MD | Los Robles Health System | Principal Investigator |
| Devi Nair, MD | St. Bernards Heart and Vascular Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grandview Medical Center | Birmingham | Alabama | 35243 | United States | ||
| Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Active Comparator: WATCHMAN / Amulet | Device | Treatment with a WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder. |
|
| Number of Participants With Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Intervention |
Participants with device or procedure-related events requiring open cardiac surgery or major endovascular intervention will be reported. |
| Up to 12 Months |
| Number of Participants Reporting Ischemic Stroke or Systemic Embolism | Participant reporting ischemic stroke or systemic embolism will be reported. Systemic embolism is defined as acute vascular insufficiency or occlusion of the extremities or any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (example; trauma, atherosclerosis, or instrumentation). | Up to 18 Months |
Device related thrombosis is defined as density attached to the implanted LAAC device in echocardiographic or computer tomography imaging. |
| Up to 12 Months |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Tucson Medical Center | Tucson | Arizona | 85712 | United States |
| Arrhythmia Research Group | Jonesboro | Arkansas | 72401 | United States |
| OC Medical Center | Fountain Valley | California | 92708 | United States |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Stanford Health Care | Palo Alto | California | 94303 | United States |
| Univeristy of California Davis Health | Rancho Cordova | California | 95670 | United States |
| Scripps Health | San Diego | California | 92121 | United States |
| Providence Saint John's Health Center and the Pacific Heart Institute | Santa Monica | California | 90404 | United States |
| Los Robles Regional Medical Center | Thousand Oaks | California | 91360 | United States |
| St Vincents Medical Center 1 | Jacksonville | Florida | 32204 | United States |
| NCH Healthcare | North Naples | Florida | 34102 | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | United States |
| The Kansas City Heart Rhythm Institute | Overland Park | Kansas | 66211 | United States |
| Ascension via Christi Hospitals Wichita Inc | Wichita | Kansas | 67214 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Englewood Health | Englewood | New Jersey | 07631 | United States |
| Northwell Health | Bay Shore | New York | 11706 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University in the City of New York and The New York and Presbyterian Hospital | New York | New York | 10032 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Wake Forest University Health Sciences | Charlotte | North Carolina | 28203 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Bethesda North Hospital Trihealth | Cincinnati | Ohio | 45202 | United States |
| Lindner Clinical Trial Center/Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Ohio Health | Columbus | Ohio | 43214 | United States |
| Trident Medical Center | North Charleston | South Carolina | 29406 | United States |
| Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| Texas Heart Institute | Houston | Texas | 77030 | United States |
| Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |
| Heart Rhythm Associates | Shenandoah | Texas | 77380 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| St Joseph Hospital and Medical Center | Tacoma | Washington | 98405 | United States |
| Mercy Hospital | Janesville | Wisconsin | 53548 | United States |
| AZORG campus Aalst Moorselbaan | Aalst | 9300 | Belgium |
| AZ Sint Jan Brugge Oostende AV | Bruges | 8000 | Belgium |
| C.H.U. Brugmann | Brussels | 1020 | Belgium |
| CHU Charleroi Chimay | Charleroi | 6042 | Belgium |
| Nemocnice na Homolce | Prague | 150 30 District 5 | Czechia |
| Rigshospitalet Copenhagen University Hospital | Copenhagen | 2100 | Denmark |
| Hopital Prive Jacques Cartier | Massy | 91300 | France |
| Clinique Pasteur | Toulouse | 31300 | France |
| MVZ CCB Frankfurt und Main Taunus GbR | Frankfurt a.M. | 60431 | Germany |
| CVC CardioVascular Center Frankfurt | Frankfurt am Main | 60389 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 22587 | Germany |
| Asklepios Klinik Altona | Hamburg | 22763 | Germany |
| Fondazione Toscana Gabriele Monasterio CNR | Massa | 54100 | Italy |
| Centro Cardiologico Monzino | Milan | 20138 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| Policlinico Tor Vergata | Roma | 00133 | Italy |
| Vilnius University Hospital Santaros Clinics | Vilnius | 08661 | Lithuania |
| St. Antonius Ziekenhuis Nieuwegein | Nieuwegein | 3435 CM | Netherlands |
| Erasmus MC | Rotterdam | 3015 GD | Netherlands |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | 61 848 | Poland |
| Hosp. de La Santa Creu I Sant Pau | Barcelona | 08025 | Spain |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp. Clinico San Carlos | Madrid | 28040 | Spain |
| Clinica Univ. de Navarra | Pamplona | 31008 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hosp. Alvaro Cunqueiro | Vigo | 36213 | Spain |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided