aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation
Public ClinicalTrials.gov record NCT02513797. 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
Left Atrial Appendage Ligation With the LARIAT™ Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation for Persistent or Longstanding Persistent Atrial Fibrillation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation. This study will be conducted in two stages: * Limited Early Stage (Stage 1): up to 250 subjects at up to 65 sites. (COMPLETED, transitioned to Stage 2) * Pivotal Stage/ Phase III (Stage 2): up to 600 subjects at up to 65 sites. (COMPLETED) All subjects from both stages will be included in the primary analysis.
Study identification
- NCT ID
- NCT02513797
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 600 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- 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
- Aug 31, 2015
- Primary completion
- Apr 20, 2021
- Completion
- Feb 28, 2022
- Last update posted
- Sep 4, 2021
2015 – 2022
United States locations
- U.S. sites
- 53
- U.S. states
- 26
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Arrhythmia Research Center | Phoenix | Arizona | 85013 | — |
| Phoenix Cardiovascular Research Group | Phoenix | Arizona | 85018 | — |
| Scripps Clinic | La Jolla | California | 92037 | — |
| University of California San Diego | La Jolla | California | 92037 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| University of California San Francisco | San Francisco | California | 94143 | — |
| Santa Barbara Cottage Hospital | Santa Barbara | California | 93103 | — |
| Stanford University | Stanford | California | 94305 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | — |
| St. Vincent's HealthCare | Jacksonville | Florida | 32204 | — |
| Piedmont Athens Regional Cardiology | Athens | Georgia | 30606 | — |
| Emory University Hospital | Atlanta | Georgia | 30342 | — |
| The Queen's Medical Center | Honolulu | Hawaii | 96813 | — |
| Northwestern University / Bluhm Cardiovascular Institute | Chicago | Illinois | 60611 | — |
| Loyola University Center for Heart and Vascular Medicine | Maywood | Illinois | 60153 | — |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | — |
| Prairie Education and Research Cooperative | Springfield | Illinois | 62769 | — |
| Northwestern Medicine Central DuPage Hospital | Winfield | Illinois | 60190 | — |
| Community Hospital | Munster | Indiana | 46321 | — |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | — |
| University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66160 | — |
| Kansas City Cardiac Arrhythmia Research | Overland Park | Kansas | 66215 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Cardiovascular Institute of the South Clinical Research Corporation | Houma | Louisiana | 70360 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| Johns Hopkins | Baltimore | Maryland | 21287 | — |
| UP Health System- Marquette | Marquette | Michigan | 49855 | — |
| St. Luke's Hospital | Kansas City | Missouri | 64111 | — |
| DaVita Medical Group | Las Vegas | Nevada | 89169 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | — |
| New Mexico Heart Institute | Albuquerque | New Mexico | 87102 | — |
| Maimonides Medical Center | Brooklyn | New York | 11219 | — |
| New York University Langone Medical Center | New York | New York | 10016 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| The Ohio Health Research Institute | Columbus | Ohio | 43214 | — |
| Southern Oregon Cardiology | Medford | Oregon | 97504 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Bryn Mawr Medical Specialists Association / Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Trident Medical Center | Charleston | South Carolina | 29406 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29466 | — |
| Vanderbilt University | Nashville | Tennessee | 37232 | — |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | — |
| Austin Heart | Austin | Texas | 78756 | — |
| Baylor - St. Luke's Medical Center | Houston | Texas | 77030 | — |
| Houston Methodist | Houston | Texas | 77030 | — |
| Baylor Plano Scott & White Research Institute Heart Hospital | Plano | Texas | 75093 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| Christus Trinity Mother Frances Health System | Tyler | Texas | 75701 | — |
| Providence Sacred Heart Medical Center | Spokane | Washington | 99204 | — |
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 NCT02513797, 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 Sep 4, 2021 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02513797 live on ClinicalTrials.gov.