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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AtriClip LAA Exclusion Device | Experimental | AtriClip delivered via minimally invasive surgical procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AtriClip LAA Exclusion Device | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 30 days post-index procedure |
| Composite Left Atrial Appendage Placement and Exclusion Success | Primary Efficacy endpoint is a success/failure endpoint with success requiring all of the following:
| Immediate to 3-months post-index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 3 months and 6 months post-index procedure |
| Serious Device or Procedure Related Adverse Event Rate |
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Inclusion Criteria:
Patient is ≥ 18 years and ≤ 80 years of age.
Patient has electrocardiographically confirmed non-valvular atrial fibrillation (paroxysmal, persistent, or longstanding persistent AF).
CHADS2 or CHA2DS2VASc score ≥2.
Patient has medical contraindication to long term anticoagulant therapy (OAC), defined as one or more of the following:
Patient is considered an acceptable surgical candidate, including use of general anesthesia.
Female patients must be of non-child bearing potential, or have a negative pregnancy test within 7 days prior to index procedure.
Exclusion Criteria:
Intraoperative Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Basel Ramlawi, MD | Methodist Hospital Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Helena Hospital | St. Helena | California | 94574 | United States | ||
| Mercy Hospital |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | AtriClip LAA Exclusion Device | AtriClip delivered via minimally invasive surgical procedure AtriClip LAA Exclusion Device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AtriClip LAA Exclusion Device | AtriClip delivered via minimally invasive surgical procedure AtriClip LAA Exclusion Device |
| 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 |
| 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 | 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:
| Posted | Number | participants | 30 days post-index procedure |
|
Incidence of Serious Adverse Events reported during the study
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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 LAA Exclusion Device | AtriClip delivered via minimally invasive surgical procedure AtriClip LAA Exclusion Device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Basel Ramlawi, MD | Methodist Hospital Houston | 713-441-5200 | basel.ramlawi@gmail.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| D001145 | Arrhythmias, Cardiac |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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. |
| 3 month and 6 month post-index procedure |
| 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. | 3 month and 6 month Post Index Procedure |
| 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. | 3 month and 6 month post-index procedure |
| Miami |
| Florida |
| 33133 |
| United States |
| Franciscan St. Francis Health | Indianapolis | Indiana | 46237 | United States |
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Aspirus | Wausau | Wisconsin | 54401 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| NYHA Functional Class | Doctors usually classify patients' heart failure according to the severity of their symptoms. The table below describes the most commonly used classification system, the New York Heart Association (NYHA) Functional Classification. It places patients in one of four categories based on how much they are limited during physical activity(http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/Classes-of-Heart-Failure\_UCM\_306328\_Article.jsp#.V8WM3md4epo). The higher the category, the more severe the symptoms. | Number | participants |
|
| CHADS2 Score | CHADS2 is based on the following: Congestive Heart Failure, Hypertension, Age (75 years or older), Diabetes Mellitus, and Stroke (history of stroke or transient ischemic attack). For each factor that is present, the patient receives one point for a total of 6 points. The higher the CHADS2 score the higher the stroke risk. | Mean | Standard Deviation | units on a scale |
|
| CHA2DSVAS Score | CHA2DS2-VASc included additional 'stroke risk modifier' risk factors to the CHADS2. CHA2DS2-VASc score was extended to include: age 65-74, female gender and vascular disease. In the CHA2DS2-VASc score, 'age 75 and above' also has extra weight, with 2 points. The maximum CHA2DS2-VASc score is 9 (for age, either the patient is ≥75 years and gets two points, is between 65-74 and gets one point, or is under 65 and get no point). The higher the CHA2DS2-VASc score, the higher the stroke risk. | Mean | Standard Deviation | units on a scale |
|
| HAS-BLED Score | A risk score to estimate the one year risk of major bleeding (i.e. intracranial, requiring hospitalization, hemoglobin decrease> 2g/L, and/or transfusion) in patients with atrial fibrillation. HAS-BLED score can range from 0 to 9 points, depending upon the number of risk factors for a given patient. HAS-BLED includes the following factors: Hypertension, Abnormal Kidney and/or Liver Function, Stroke (previous history of stroke, especially deep brain (lacunar) stroke), Bleeding, Labile INR, Elderly (>65 years) and Drugs and/or alcohol. The higher the score, the higher the risk of bleeding. | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Composite Left Atrial Appendage Placement and Exclusion Success | Primary Efficacy endpoint is a success/failure endpoint with success requiring all of the following:
| Ten (10) patients were treated, however the AtriClip® device was not implanted in one (1) patient. | Posted | Number | participants | Immediate to 3-months post-index procedure |
|
|
|
| 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:
| Posted | Number | participants | 3 months and 6 months post-index procedure |
|
|
|
| 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. | Posted | Number | participants | 3 month and 6 month post-index procedure |
|
|
|
| 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. | All treated patients. | Posted | Number | participants | 3 month and 6 month Post Index Procedure |
|
|
|
| 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. | All treated patients. | Posted | Number | participants | 3 month and 6 month post-index procedure |
|
|
|
| 5 |
| 10 |
| 8 |
| 10 |
| Pnemonia | Infections and infestations | Systematic Assessment |
|
| Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Carinoid tumor pulmonary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cardiovascular Deconditioning | Cardiac disorders | Systematic Assessment |
|
| Diastolic Dysfunction | Cardiac disorders | Systematic Assessment |
|
| Sick Sinus Sundrome | Cardiac disorders | Systematic Assessment |
|
| Cataract | Eye disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| Rectal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Accident at Home | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Radius Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Biopsy Lung Abnormal | Investigations | Systematic Assessment |
|
| Troponin Increased | Investigations | Systematic Assessment |
|
| Electrolyte Imbalance | Metabolism and nutrition disorders | Systematic Assessment |
|
| Carinoid Tumor Pulmonary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Altered State of Consciousness | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Diabetic Nephropathy | Renal and urinary disorders | Systematic Assessment |
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| Oliguria | Renal and urinary disorders | Systematic Assessment |
|
| Renal Colic | Renal and urinary disorders | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiatory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cataract Operation | Surgical and medical procedures | Systematic Assessment |
|
| Haematoma | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | Systematic Assessment |
|
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| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
| Title | Measurements |
|---|---|
|
| Neoplasms Benign (Carcinoid Tumor Pulmonary) |
|
| Respiratory Failure |
|
| Title | Measurements |
|---|---|
|
| Gastrointestinal Disorder |
|
| General Disorder |
|
| Immune Disorder (Seasonal Allergy) |
|
| Infections and Infestations |
|
| Injury (Accident at Home, Radius Fracture) |
|
| Investigations |
|
| Metabolism and Nutrition Disorder |
|
| Neoplasms Benign (Carcinoid Tumor Pulmonary) |
|
| Nervous System Disorder |
|
| Psychiatric Disorder |
|
| Renal and Urinary Disorder |
|
| Respiratory Disorder |
|
| Surgical and Medical Procedure |
|
| Vascular Disorder |
|