Atrial Fibrillation, Persistent or Longstanding Persistent Atrial Fibrillation
Conditions
Brief summary
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
Detailed description
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.
Interventions
DEVICEAtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
Sponsors
AtriCure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
1. AF \>10 years. 2. Refractory hypertension, defined as systolic (\>150 mm Hg) or diastolic (\> 90 mm Hg) blood pressure that remains uncontrolled despite sustained therapy 3. History of pulmonary hypertension 4. Pulmonary vein stenosis in one or more of the pulmonary veins 5. EP catheter ablation procedure to treat atrial fibrillation within 3 months 6. Undergone prior cardiothoracic surgery, previous thorax trauma which resulted in a pneumothorax or hemothorax. 7. Sleep apnea, home oxygen therapy, moderate to severe COPD, (FEV1/FVC \< 70% predicted) or patient is considered intolerant to single lung ventilation. 8. NYHA Class IV heart failure. 9. Uncorrected, reversible cause(s) of atrial fibrillation, or is currently being treated for arrhythmias other than atrial fibrillation (AF) or atrial flutter. 10. Documented history of previous catheter ablation with perforation, history of pericarditis, pericardial effusion, or tamponade. 11. Structural heart disease requiring surgical treatment (i.e. valve disease requiring repair or replacement within 12 months following surgical ablation procedure). 12. CAD requiring intervention (either surgical, i.e. CABG, or catheter). 13. Ejection fraction \< 30% 14. Measured left atrial diameter \> 5.5 cm 15. Stroke/cerebrovascular accident (CVA) within previous six months, carotid artery stenosis greater than 80%. 16. BMI is \>40 17. Thrombus in the left atrium or the left atrial appendage, determined by echocardiography (either at baseline TTE (or equivalent diagnostic test) or intraoperative TEE). 18. Blood dyscrasia or clotting disorder (i.e. Idiopathic Thrombocytopenic Purpura \[ITP\] or Thrombotic Thrombocytopenic Purpura \[TTP\]). 19. Contraindication to anticoagulation that in the opinion of the investigator poses undue risk to the patient from participating in the endocardial EP procedure. 20. Documented thromboembolism within the previous six months prior to signing informed consent. 21. Has the following atrial myxoma, mural thrombus or mural tumor. 22. A condition or congenital anomaly which prevents required surgical or catheter access. 23. A co-morbid condition that, in the opinion of the investigator, poses undue risk of general anesthesia or port access cardiac surgery. 24. Currently abusing drugs or alcohol. 25. Currently or has participated in a clinical study in the last 3 months prior to signing informed consent. 26. A psychological disorder that could interfere with provision of informed consent, completion of tests, therapy, or follow-up. 27. A condition that, in the opinion of the investigator, may jeopardize the patient's well-being and/or the soundness of this clinical study. 28. Pre-existing esophageal condition that required (or requires) endoscopic therapy or surgical treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint | 6 months post the Endocaridal Ablation Procedure through the 12 month follow-up visit | 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). |
| Primary Safety Endpoint | 30 Days | 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: 1. The AtriCure Bipolar System and/or the AtriClip Pro LAA Exclusion System, within 30 days following the epicardial surgical ablation procedure; or 2. The epicardial surgical ablation procedure within 30 days following the epicardial procedure; or 3. The endocardial index procedure (or a repeat endocardial ablation procedure performed during the blanking period) within 7 days following an endocardial ablation procedure. |
Countries
Belgium, Netherlands, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 90 |
| Total | 90 |
Baseline characteristics
| Characteristic | AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 42 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 90 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 87 Participants |
| Region of Enrollment Belgium | 14 participants |
| Region of Enrollment Netherlands | 7 participants |
| Region of Enrollment United States | 69 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 90 |
| other Total, other adverse events | 23 / 90 |
| serious Total, serious adverse events | 24 / 90 |
Outcome results
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).
Time frame: 6 months post the Endocaridal Ablation Procedure through the 12 month follow-up visit
Population: Modified Intent to Treat (mITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System | Primary Effectiveness Endpoint | 61 Participants |
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: 1. The AtriCure Bipolar System and/or the AtriClip Pro LAA Exclusion System, within 30 days following the epicardial surgical ablation procedure; or 2. The epicardial surgical ablation procedure within 30 days following the epicardial procedure; or 3. The endocardial index procedure (or a repeat endocardial ablation procedure performed during the blanking period) within 7 days following an endocardial ablation procedure.
Time frame: 30 Days
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System | Primary Safety Endpoint | 6 Participants |