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Retrospective-prospective, multi-center, non-randomized, unblinded, post-market study to evaluate the long-term performance and safety of AtriClip® FLEX-V LAA and PRO•V LAA Exclusion devices for exclusion of the left atrial appendage of the heart during concomitant cardiac procedures.
The goal of this clinical trial is to evaluate the long-term performance and safety of AtriClip® FLEX-V LAA and PRO•V LAA Exclusion devices for exclusion of the left atrial appendage of the heart during concomitant cardiac procedures in participants for which a VCLIP was placed previously. Participants are consented and evaluated to confirm long-term performance of the AtriClip®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AtriClip group | Experimental | Subjects eligible for evaluation are those who had undergone designated non-emergent, cardiac surgical procedure(s), received an AtriClip implant (with devices under investigation) and who were willing to return for follow-up chest imaging to ascertain Left Atrial Appendage (LAA) exclusion and met inclusion exclusion criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AtriClip | Device | Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Performance Endpoint | Left Atrial Appendage exclusion defined as absence of residual communication (≤3 mm residual communication with LAA) between the left atrium (LA) and the LAA as assessed by CTA or TEE imaging at the last follow-up visit. The images will be reviewed by an independent core lab using a standardized imaging protocol. | 12-months or greater post-procedure, an average of 1.5 years |
| Primary Safety Endpoint | Incidence of the following serious adverse events within 30-days, if related tot he device and/or implant procedure:
| 30-days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Performance | A residual LAA neck ≤10 mm as assessed by CTA or TEE imaging at the last follow-up visit | 12-months or greater post-procedure, an average of 1.5 years |
| Long-term Thromboembolic Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elias Zias, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franciscan Health | Indianapolis | Indiana | 46237 | United States | ||
| Washington University School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | AtriClip Group | AtriClip: Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants Enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | AtriClip Group | AtriClip: Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 1 subject withdrew participation prior to index procedure |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Performance Endpoint | Left Atrial Appendage exclusion defined as absence of residual communication (≤3 mm residual communication with LAA) between the left atrium (LA) and the LAA as assessed by CTA or TEE imaging at the last follow-up visit. The images will be reviewed by an independent core lab using a standardized imaging protocol. | Posted | Count of Participants | Participants | 12-months or greater post-procedure, an average of 1.5 years |
|
|
12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AtriClip Group | AtriClip: Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia Needing Medical Treatment (new onset) | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randall Lee, VP Medical Affairs, Clinical Affairs | AtriCure | 650-347-0419 | RLee@atricure.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2021 | Nov 20, 2024 | Prot_SAP_000.pdf |
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Incidence of thromboembolic events (ischemic stroke, TIA, systemic embolism) of any cause through the last follow-up visit.
| 12-months or greater post-procedure, an average of 1.5 years |
| Device and Procedure Long-term Safety | Number of Participants with Device or Procedure Related SAEs through the last follow-up visit | 12-months or greater post-procedure, an average of 1.5 years |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| NYU | New York | New York | 10016 | United States |
| Mount Sinai | New York | New York | 10029 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Mercy Health Cincinnati | Cincinnati | Ohio | 45237 | United States |
| Toledo Hospital | Toledo | Ohio | 43604 | United States |
| Prisma Health | Greenville | South Carolina | 29601 | United States |
| Centra Lynchburg General Hospital | Lynchburg | Virginia | 24501 | United States |
| Aurora Research Institute LLC | Milwaukee | Wisconsin | 53215 | United States |
| Count of Participants |
| Participants |
|
| Age, Continuous | 1 subject withdrew participation before index procedure | Median | Full Range | years |
|
| Sex: Female, Male | Measure Analysis Population Description: 1 subject withdrew participation prior to index procedure | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 1 subject withdrew participation before index procedure | Count of Participants | Participants |
|
|
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| Primary | Primary Safety Endpoint | Incidence of the following serious adverse events within 30-days, if related tot he device and/or implant procedure:
| Posted | Count of Participants | Participants | 30-days post-procedure |
|
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|
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| Secondary | Performance | A residual LAA neck ≤10 mm as assessed by CTA or TEE imaging at the last follow-up visit | Posted | Count of Participants | Participants | 12-months or greater post-procedure, an average of 1.5 years |
|
|
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| Secondary | Long-term Thromboembolic Events | Incidence of thromboembolic events (ischemic stroke, TIA, systemic embolism) of any cause through the last follow-up visit. | Posted | Count of Participants | Participants | 12-months or greater post-procedure, an average of 1.5 years |
|
|
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| Secondary | Device and Procedure Long-term Safety | Number of Participants with Device or Procedure Related SAEs through the last follow-up visit | Posted | Count of Participants | Participants | 12-months or greater post-procedure, an average of 1.5 years |
|
|
|
| 0 |
| 155 |
| 76 |
| 155 |
| 0 |
| 155 |
| Pleural Effusion | Blood and lymphatic system disorders | Systematic Assessment |
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| Bleeding Event | Blood and lymphatic system disorders | Systematic Assessment |
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| GI Bleed | Gastrointestinal disorders | Systematic Assessment |
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| Hernia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Sepsis | Immune system disorders | Systematic Assessment |
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| Angina | Cardiac disorders | Systematic Assessment |
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| Bowel Obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Vascular Disease | Cardiac disorders | Systematic Assessment |
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| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Conduction Disturbance | Immune system disorders | Systematic Assessment |
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| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
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| Myocardial Infraction | Cardiac disorders | Systematic Assessment |
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| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| TIA or Neurological Deficit | Nervous system disorders | Systematic Assessment | (lasting <24h) without Infraction |
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| Aphasia | Nervous system disorders | Systematic Assessment |
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| Atrial Fibrillation with Rapid Ventricular rate | Cardiac disorders | Systematic Assessment |
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| AV block requiring permanent pacemaker (new onset) | Cardiac disorders | Systematic Assessment |
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| Hemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Left foot partial 1st ray amputation | Surgical and medical procedures | Systematic Assessment |
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| Nausea and Abdominal Pain-Dehydration | General disorders | Systematic Assessment |
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| Pericarditis | Cardiac disorders | Systematic Assessment |
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| Post operative ileus requiring decompressive colonoscopy | Surgical and medical procedures | Systematic Assessment |
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| Pulmonary Embolism | Cardiac disorders | Systematic Assessment |
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| Renal Insufficiency | Renal and urinary disorders | Systematic Assessment |
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| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sinus Node Dysfunction | Cardiac disorders | Systematic Assessment |
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| Sternal Dehiscence | Cardiac disorders | Systematic Assessment |
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| Stroke, Other (Cardioembolic) | Cardiac disorders | Systematic Assessment |
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| Stroke, Ischemic | Cardiac disorders | Systematic Assessment |
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| Thrombus | Cardiac disorders | Systematic Assessment |
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| Thrombocytopenia | Cardiac disorders | Systematic Assessment |
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| Tricuspid Valve Regurgitation | Cardiac disorders | Systematic Assessment |
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| Excessive Bleeding r/t Procedure (req >2u Blood or intervention) | General disorders | Systematic Assessment |
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