A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage Elimination
Public ClinicalTrials.gov record NCT06168942. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
LAM202403: Laminar Left Atrial Appendage Elimination (LAAX) Pivotal IDE Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT06168942
- Recruitment status
- Suspended
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,500 participants
Conditions and interventions
Interventions
- Experimental: Laminar Left Atrial Appendage Closure System Device
- Active Comparator: WATCHMAN / Amulet Device
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 19, 2024 (Actual)
- Primary completion
- Dec 1, 2028 (Estimated)
- Completion
- Feb 29, 2032 (Estimated)
- Last update posted
- Oct 19, 2026
2024 – 2032
United States locations
- U.S. sites
- 36
- U.S. states
- 16
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Grandview Medical Center | Birmingham | Alabama | 35243 | — |
| Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG | Phoenix | Arizona | 85018 | — |
| Tucson Medical Center | Tucson | Arizona | 85712 | — |
| Arrhythmia Research Group | Jonesboro | Arkansas | 72401 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| Stanford Health Care | Palo Alto | California | 94303 | — |
| Univeristy of California Davis Health | Rancho Cordova | California | 95670 | — |
| Scripps Health | San Diego | California | 92121 | — |
| Providence Saint John's Health Center and the Pacific Heart Institute | Santa Monica | California | 90404 | — |
| Los Robles Regional Medical Center | Thousand Oaks | California | 91360 | — |
| NCH Healthcare | North Naples | Florida | 34102 | — |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | — |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | — |
| The Kansas City Heart Rhythm Institute | Overland Park | Kansas | 66211 | — |
| Ascension via Christi Hospitals Wichita Inc | Wichita | Kansas | 67214 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Northwell Health | Bay Shore | New York | 11706 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Columbia University in the City of New York and The New York and Presbyterian Hospital | New York | New York | 10032 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Wake Forest University Health Sciences | Charlotte | North Carolina | 28203 | — |
| Bethesda North Hospital Trihealth | Cincinnati | Ohio | 45202 | — |
| Lindner Clinical Trial Center/Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Ohio Health | Columbus | Ohio | 43214 | — |
| Trident Medical Center | North Charleston | South Carolina | 29406 | — |
| Centennial Medical Center | Nashville | Tennessee | 37203 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | — |
| Heart Rhythm Associates | Shenandoah | Texas | 77380 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
| St Joseph Hospital and Medical Center | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06168942, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 19, 2026 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06168942 live on ClinicalTrials.gov.