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The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation
The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation utilizing the AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System in an endoscopic or open ablation procedure, followed by an endocardial mapping and ablation procedure utilizing commercially available RF based, irrigated, power controlled, ablation catheters for endocardial lesions. The endocardial procedure will be staged to occur after 90 days post epicardial surgical procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System | Experimental | AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System at day 1 of surgical procedure followed by endocardial catheter ablation procedure to occur at approximately 90 days after day 1 of surgical procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint | Freedom from any documented AF, atrial flutter, or atrial tachycardia lasting >30 seconds in duration through the 12 month follow-up visit in the absence of Class I or III AADs (with the exception of previously failed AADs at doses not exceeding those previously failed). | 6 months post the Endocaridal Ablation Procedure through the 12 month follow-up visit |
| Primary Safety Endpoint | The primary safety endpoint is a composite endpoint consisting of any one or more of the events if they were adjudicated by the CEC to be serious adverse events (SAEs) and related to device/procedures as follows:
| 30 Days |
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Inclusion Criteria:
1. Symptomatic Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation refractory to a minimum of one Class I or Class III AADs.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Ellenbogen, MD | VCU | Principal Investigator |
| Vigneshwar Kasirajan, MD | VCU | Principal Investigator |
| Ali Khoynezhad, MD | MemorialCare Long Beach Medical Ctr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach Memorial Medical Center | Long Beach | California | 90806 | United States | ||
| Cedars-Sinai Heart Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41025224 | Derived | Ellenbogen KA, Khoynezhad A, La Meir M, de Asmundis C, Koneru JN, Johnkoski J, Rist K, Mumtaz M, Link MG, de Groot JR, Driessen AHG, Lee MY, Hoff SJ, Bello D, Dunnington G, Eisenberg S, Vloka M, Taylor BJ, Jones SD, Philpott JM, Beaver TM, Miles WM, Khan JH, Kang S, Gandhi GD, Okum EJ, Badhwar N, Baykaner T, Lee AM, Vesco PA, Smith JM, Gaynor S, Frazier K, Lee RJ, Kasirajan V. Dual Epicardial and Endocardial Procedure (DEEP) for Persistent or Longstanding Persistent Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2025 Oct;18(10):e013692. doi: 10.1161/CIRCEP.125.013692. Epub 2025 Sep 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System | AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System at day 1 of surgical procedure followed by endocardial catheter ablation procedure to occur at approximately 90 days after day 1 of surgical procedure. AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 11, 2021 | Nov 20, 2024 |
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| Los Angeles |
| California |
| 90048 |
| United States |
| Alta Bates Sutter Medical Center, East Bay Hospital | Oakland | California | 94609 | United States |
| St. Helena Hospital, Adventist Heart Institute | St. Helena | California | 94574 | United States |
| Stanford University Department of CV medicine | Stanford | California | 94305 | United States |
| Shands at the University of Florida | Gainesville | Florida | 32610 | United States |
| Orlando Heart Institute | Orlando | Florida | 32806 | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| Saint Alphonsus Regional Medical Center | Boise | Idaho | 83706 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Tri Health Hosptial - Good Samaritan and Bethesda North Hospitals | Cincinnati | Ohio | United States |
| Pinnacle Health | Harrisburg | Pennsylvania | 17104 | United States |
| Sentara Cardiovascular Research Institute | Norfolk | Virginia | 23507 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Aspirus Research Institute | Wausau | Wisconsin | 54401 | United States |
| Universitair Ziekenhuis Brussel (UZ Brussels) | Brussels | Belgium |
| Academic Medical Center (AMC) | Amsterdam | Netherlands |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System | AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System at day 1 of surgical procedure followed by endocardial catheter ablation procedure to occur at approximately 90 days after day 1 of surgical procedure. AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 Effectiveness Endpoint | Freedom from any documented AF, atrial flutter, or atrial tachycardia lasting >30 seconds in duration through the 12 month follow-up visit in the absence of Class I or III AADs (with the exception of previously failed AADs at doses not exceeding those previously failed). | Modified Intent to Treat (mITT) | Posted | Count of Participants | Participants | 6 months post the Endocaridal Ablation Procedure through the 12 month follow-up visit |
|
|
| ||||||||||||||||||||||||||
| Primary | Primary Safety Endpoint | The primary safety endpoint is a composite endpoint consisting of any one or more of the events if they were adjudicated by the CEC to be serious adverse events (SAEs) and related to device/procedures as follows:
| Safety Population | Posted | Count of Participants | Participants | 30 Days |
|
|
24 months
All adverse events that occurred within 24 months post procedure were collected
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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 | AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System | AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System at day 1 of surgical procedure followed by endocardial catheter ablation procedure to occur at approximately 90 days after day 1 of surgical procedure. AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation | 1 | 90 | 24 | 90 | 23 | 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| Atrial tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Atrioventricular block | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Pulseless electrical activity | Cardiac disorders | Systematic Assessment |
| ||
| Sick sinus syndrome | Cardiac disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Large intestine polyp | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bursitis infective | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile colitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumococcal sepsis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Atrio-oesophageal fistula | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Diaphragmatic injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Postoperative ileus | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Ischaemic stroke | Nervous system disorders | Systematic Assessment |
| ||
| Lumbar radiculopathy | Nervous system disorders | Systematic Assessment |
| ||
| Metabolic encephalopathy | Nervous system disorders | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Apnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pharyngeal haematoma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Air embolism | Vascular disorders | Systematic Assessment |
| ||
| Aortic aneurysm | Vascular disorders | Systematic Assessment |
| ||
| Femoral artery aneurysm | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericarditis | Cardiac disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nfii Ndikintum | AtriCure, Inc. | 1-513-755-4100 | nndikintum@atricure.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 25, 2023 | Nov 20, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
|