AFib, Atrial Fibrillation
Conditions
Keywords
Left Atrial Appendage, LAA, Atrial Fibrillation, AFib, AF, IRB approved, clinical, Stroke, TIA, contraindication to oral anticoagulation therapy, Arrhythmias, Cardiac, OAC, trial, study, LAA occlusion, occluded, prevent
Brief summary
This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage. The purpose is for evaluation of Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation who are unable to take Oral Anticoagulants.
Interventions
DEVICEAtriClip LAA Exclusion Device
Sponsors
AtriCure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is ≥ 18 years and ≤ 80 years of age. 2. Patient has electrocardiographically confirmed non-valvular atrial fibrillation (paroxysmal, persistent, or longstanding persistent AF). 3. CHADS2 or CHA2DS2VASc score ≥2. 4. Patient has medical contraindication to long term anticoagulant therapy (OAC), defined as one or more of the following: * history of intracranial bleeding (e.g. due to amyloid angiopathy or other condition) which renders patient unsafe for OAC; * history of gastrointestinal, genitourinary, or respiratory tract bleeding due to permanent condition which renders patient unsafe for OAC; * HAS-BLED Score ≥ 3. 5. Patient is considered an acceptable surgical candidate, including use of general anesthesia. 6. Female patients must be of non-child bearing potential, or have a negative pregnancy test within 7 days prior to index procedure.
Exclusion criteria
1. Stroke within 30 days, or TIA within 3 days, respectively, prior to index procedure. 2. Documented medical history of any penetrating trauma to thorax, or blunt trauma to thorax which resulted in a left pneumothorax or left hemothorax. 3. Myocardial infarction within 60 days prior to index procedure. 4. NYHA Class IV heart failure. 5. Ejection fraction \< 40% (based on baseline transthoracic echocardiography (TTE)). 6. Prior attempted obliteration of left atrial appendage (percutaneous or open cardiac surgery). 7. Previous catheter ablation with perforation or complication. 8. Prior open cardiac surgery, or percutaneous coronary intervention with associated unintended cardiac perforation, or pericardial adhesions are suspected. 9. History of pericarditis or pericardiocentesis. 10. Active infection, septicemia, or fever of unknown origin. 11. Concomitant elective surgical procedure (in addition to AtriClip placement) at the time of index procedure. 12. Planned atrial arrhythmia ablation procedure within six months following index procedure. 13. Underlying structural heart disease requiring planned surgical treatment within six months following the index procedure. 14. Cardiac or thoracic surgical procedure within the thirty days prior to index procedure. 15. Anticoagulation therapy for other medical condition (i.e. deep vein thrombosis) is required. 16. Patient unable to discontinue thienopyridines (e.g. clopidogrel) or non-ASA antiplatelet agents 4 days pre-operatively and abstain for at least 2 days post-operatively. 17. Renal Failure as defined by creatinine \> 2.0 mg/dl (\> 152.5 umol/L) and/or need for dialysis. 18. Known carotid artery diameter stenosis greater than 80%. 19. Patient has symptomatic or high-grade carotid disease (\>70% bilaterally). 20. Patient unable or unwilling to undergo transesophageal echocardiography (TEE). 21. Presence of thrombus in the left atrium or LAA, as determined by baseline TTE or Computed Tomography Angiogram (CTA). 22. Documented history of thrombophilic disorder, with diagnosis established via previous objective testing (e.g. familial screening for thrombophilia). 23. Moderate to Severe Chronic Obstructive Pulmonary Disease (FEV1 or VC\<70% predicted) or intolerant of single lung ventilation. 24. History of Hypercoagulopathy 25. Body Mass Index (BMI) \> 35. 26. Other medical illness or comorbidity that may cause non-compliance with the protocol, confound data interpretation (e.g. severe dementia), or limited life expectancy (i.e. \< 3 months). 27. Enrolled in another investigational device or drug study at the time of enrollment and during the course of the study. 28. Psychiatric disorder which in the judgment of the investigator could interfere with informed consent, completion of tests, therapy, or follow-up. 29. Patient is pregnant or intends to become pregnant within 6 months post-index procedure. Intraoperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Serious Adverse Events Within 30 Days Post-Index Procedure | 30 days post-index procedure | The primary safety endpoint consists of the following serious adverse events within 30 days post-index procedure (unless otherwise noted), as adjudicated by Independent Physician Adjudicator: * Serious Injury to the cardiac structure or other body structure deemed to be related to the delivery or placement of the Clip * Cardiac-Related Death, Myocardial Infarction, or Ischemic Stroke * Major bleeding (defined as requiring re-operation and/or transfusion (\> 2 U packed red blood cells (PRBC)) within any 24 hour period during the first 2 days post-index procedure or at any time point if attributed to the device/index procedure). |
| Composite Left Atrial Appendage Placement and Exclusion Success | Immediate to 3-months post-index procedure | Primary Efficacy endpoint is a success/failure endpoint with success requiring all of the following: 1. Patient Technical Success: The ability to successfully implant an AtriClip device at the LAA in a patient. 2. Intra-Procedural Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (\<3 mm residual communication with LAA and \<10 mm residual pocket) between the LA and LAA, assessed intra-procedurally by TEE. 3. 3 Month Follow-Up Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (\<3 mm residual communication with LAA and \< 10mm residual pocket) between the LA and LAA at \>=3 month TEE or CTA evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Stroke and Non-CNS Systemic Embolism | 3 months and 6 months post-index procedure | The secondary efficacy endpoints will be a composite of the following events within 3 months and 6 months post-index procedure: 1. Stroke (ischemic ) 2. Non-CNS (Central Nervous System) systemic embolism. |
| Serious Device or Procedure Related Adverse Event Rate | 3 month and 6 month post-index procedure | Overall Serious Device or Procedure Related Adverse Event Rate: Incidence of all serious device or procedure related adverse events observed through the 3 month and 6 month follow-up assessments as adjudicated by Independent Physician Adjudicator. |
| Overall Serious Adverse Event Rate | 3 month and 6 month Post Index Procedure | Overall Serious Adverse Event Rate: Incidence of all serious adverse events, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator. |
| Overall Adverse Event Rate | 3 month and 6 month post-index procedure | Overall Adverse Event Rate: Incidence of all device and procedure related adverse events and any neurological related AEs, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator. |
Countries
United States
Participant flow
Recruitment details
The first subject was enrolled (defined as signed informed consent) on March 25, 2014. The last subject completed their final visit as of July 31, 2015. A total of 13 subjects were enrolled from 4 sites. Of the 13 enrolled subjects, 10 were treated (defined as attempted surgery) with the investigational device.
Participants by arm
| Arm | Count |
|---|---|
| AtriClip LAA Exclusion Device AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | AtriClip LAA Exclusion Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 72 Years STANDARD_DEVIATION 8.85 |
| CHA2DSVAS Score | 4.6 units on a scale STANDARD_DEVIATION 0.84 |
| CHADS2 Score | 2.9 units on a scale STANDARD_DEVIATION 0.88 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Gender Female | 4 Participants |
| Gender Male | 7 Participants |
| HAS-BLED Score | 3.6 units on a scale STANDARD_DEVIATION 0.7 |
| NYHA Functional Class III (Marked limitation) | 0 participants |
| NYHA Functional Class II (Mild symptoms and slight limitation) | 3 participants |
| NYHA Functional Class I (No symptoms and no limitations) | 6 participants |
| NYHA Functional Class IV (Severe limitations) | 0 participants |
| NYHA Functional Class No Heart Block | 1 participants |
| NYHA Functional Class Not Reported | 1 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 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 | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 10 |
| serious Total, serious adverse events | 5 / 10 |
Outcome results
Primary
Composite Left Atrial Appendage Placement and Exclusion Success
Primary Efficacy endpoint is a success/failure endpoint with success requiring all of the following: 1. Patient Technical Success: The ability to successfully implant an AtriClip device at the LAA in a patient. 2. Intra-Procedural Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (\<3 mm residual communication with LAA and \<10 mm residual pocket) between the LA and LAA, assessed intra-procedurally by TEE. 3. 3 Month Follow-Up Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (\<3 mm residual communication with LAA and \< 10mm residual pocket) between the LA and LAA at \>=3 month TEE or CTA evaluation.
Time frame: Immediate to 3-months post-index procedure
Population: Ten (10) patients were treated, however the AtriClip® device was not implanted in one (1) patient.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AtriClip LAA Exclusion Device | Composite Left Atrial Appendage Placement and Exclusion Success | 8 participants |
Primary
Number of Serious Adverse Events Within 30 Days Post-Index Procedure
The primary safety endpoint consists of the following serious adverse events within 30 days post-index procedure (unless otherwise noted), as adjudicated by Independent Physician Adjudicator: * Serious Injury to the cardiac structure or other body structure deemed to be related to the delivery or placement of the Clip * Cardiac-Related Death, Myocardial Infarction, or Ischemic Stroke * Major bleeding (defined as requiring re-operation and/or transfusion (\> 2 U packed red blood cells (PRBC)) within any 24 hour period during the first 2 days post-index procedure or at any time point if attributed to the device/index procedure).
Time frame: 30 days post-index procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AtriClip LAA Exclusion Device | Number of Serious Adverse Events Within 30 Days Post-Index Procedure | 0 participants |
Secondary
Overall Adverse Event Rate
Overall Adverse Event Rate: Incidence of all device and procedure related adverse events and any neurological related AEs, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator.
Time frame: 3 month and 6 month post-index procedure
Population: All treated patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AtriClip LAA Exclusion Device | Overall Adverse Event Rate | Psychiatric Disorder | 1 participants |
| AtriClip LAA Exclusion Device | Overall Adverse Event Rate | Blood and Lymphatic System Disorders (Anaemia) | 3 participants |
| AtriClip LAA Exclusion Device | Overall Adverse Event Rate | Cardiac Disorder | 3 participants |
| AtriClip LAA Exclusion Device | Overall Adverse Event Rate | Eye Disorder (Cataract) | 1 participants |
| AtriClip LAA Exclusion Device | Overall Adverse Event Rate | Gastrointestinal Disorder | 3 participants |
| AtriClip LAA Exclusion Device | Overall Adverse Event Rate | General Disorder | 3 participants |
| AtriClip LAA Exclusion Device | Overall Adverse Event Rate | Immune Disorder (Seasonal Allergy) | 1 participants |
| AtriClip LAA Exclusion Device | Overall Adverse Event Rate | Infections and Infestations | 5 participants |
| AtriClip LAA Exclusion Device | Overall Adverse Event Rate | Injury (Accident at Home, Radius Fracture) | 2 participants |
| AtriClip LAA Exclusion Device | Overall Adverse Event Rate | Investigations | 2 participants |
| AtriClip LAA Exclusion Device | Overall Adverse Event Rate | Metabolism and Nutrition Disorder | 1 participants |
| AtriClip LAA Exclusion Device | Overall Adverse Event Rate | Neoplasms Benign (Carcinoid Tumor Pulmonary) | 1 participants |
| AtriClip LAA Exclusion Device | Overall Adverse Event Rate | Nervous System Disorder | 1 participants |
| AtriClip LAA Exclusion Device | Overall Adverse Event Rate | Renal and Urinary Disorder | 2 participants |
| AtriClip LAA Exclusion Device | Overall Adverse Event Rate | Respiratory Disorder | 4 participants |
| AtriClip LAA Exclusion Device | Overall Adverse Event Rate | Surgical and Medical Procedure | 1 participants |
| AtriClip LAA Exclusion Device | Overall Adverse Event Rate | Vascular Disorder | 2 participants |
Secondary
Overall Serious Adverse Event Rate
Overall Serious Adverse Event Rate: Incidence of all serious adverse events, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator.
Time frame: 3 month and 6 month Post Index Procedure
Population: All treated patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AtriClip LAA Exclusion Device | Overall Serious Adverse Event Rate | Infections and Infestations | 2 participants |
| AtriClip LAA Exclusion Device | Overall Serious Adverse Event Rate | Cardiac Disorder | 3 participants |
| AtriClip LAA Exclusion Device | Overall Serious Adverse Event Rate | General Disorder | 1 participants |
| AtriClip LAA Exclusion Device | Overall Serious Adverse Event Rate | Neoplasms Benign (Carcinoid Tumor Pulmonary) | 1 participants |
| AtriClip LAA Exclusion Device | Overall Serious Adverse Event Rate | Respiratory Failure | 1 participants |
Secondary
Rate of Stroke and Non-CNS Systemic Embolism
The secondary efficacy endpoints will be a composite of the following events within 3 months and 6 months post-index procedure: 1. Stroke (ischemic ) 2. Non-CNS (Central Nervous System) systemic embolism.
Time frame: 3 months and 6 months post-index procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AtriClip LAA Exclusion Device | Rate of Stroke and Non-CNS Systemic Embolism | 0 participants |
Secondary
Serious Device or Procedure Related Adverse Event Rate
Overall Serious Device or Procedure Related Adverse Event Rate: Incidence of all serious device or procedure related adverse events observed through the 3 month and 6 month follow-up assessments as adjudicated by Independent Physician Adjudicator.
Time frame: 3 month and 6 month post-index procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AtriClip LAA Exclusion Device | Serious Device or Procedure Related Adverse Event Rate | 0 participants |