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The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in treating AF, and how effective this combined procedure is using the AtriCure System in treating AF. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AtriCure Bipolar System combined with a catheter ablation | Experimental | procedure using the AtriCure Bipolar System plus a catheter ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid: AtriCure Bipolar System & EP ablation procedure | Device | AtriCure Bipolar System plus a catheter ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint | Acute MAE within 30 days post procedure or hospital discharge (up to 7 days), whichever is longer. | Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer. |
| Absence of Atrial Fibrillation | Absence of atrial fibrillation (AF) at twelve month follow-up based on an auto trigger event monitor, while off all Class I and III antiarrhythmic therapy. | 12 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Serious Device or Procedure Related Adverse Event Rate | 12 month follow-up | |
| Acute Procedure Success | Upon completion of the index procedure, up to ten hours | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States | ||
| Vanderbilt Heart Institute |
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Participants were recruited at 5 academic medical centers. The first participant was enrolled in December 2010 and the last participant was enrolled in October 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | AtriCure Bipolar System Combined With a Catheter Ablation | Procedure using the AtriCure Bipolar System plus a catheter ablation Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AtriCure Bipolar System Combined With a Catheter Ablation | Procedure using the AtriCure Bipolar System plus a catheter ablation Hybrid ablation procedure: AtriCure Bipolar System plus a catheter 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 |
| 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 Safety Endpoint | Acute MAE within 30 days post procedure or hospital discharge (up to 7 days), whichever is longer. | Posted | Number | 95% Confidence Interval | percentage of participants | Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer. |
|
|
Treatment to 24 months
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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 Combined With a Catheter Ablation | Procedure using the AtriCure Bipolar System plus a catheter ablation Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Embolic Stroke | Nervous system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Embolic Stroke | Nervous system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Affairs and Biometrics | AtriCure | 1-513-644-8192 | nndikintum@atricure.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Absence of Atrial Fibrillation |
Absence of atrial fibrillation after the 3 month blanking period through twelve month follow-up based on auto trigger event monitor. |
| After the 3 month blanking period through twelve month follow-up. |
| Number of Participants With Reintervention to Address Atrial Dysrhythmia | Number of Participants with Reintervention to Address Atrial Dysrhythmia, through 12 months | 12 months |
| Number of Participants With DC Cardioversion | 12 months |
| Improvement in AF | Improvement in Atrial Fibrillation Symptom Checklist Frequency (Minimum value: -1.0, Maximum value: 25.0) and Severity Scores (Minimum value: -6.0, Maximum value: 19.0) | 12 months |
| Duration of Procedure | During index procedure |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| Baylor Health | Plano | Texas | 75093 | United States |
| UVA | Charlottesville | Virginia | 22908 | United States |
| Sentara Norfolk | Norfolk | Virginia | 23507 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | inches |
|
| Weight | Mean | Standard Deviation | pounds |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
| Primary | Absence of Atrial Fibrillation | Absence of atrial fibrillation (AF) at twelve month follow-up based on an auto trigger event monitor, while off all Class I and III antiarrhythmic therapy. | Denominators (19) are subjects who are evaluable for primary efficacy endpoint. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 month follow-up |
|
|
|
| Secondary | Overall Serious Device or Procedure Related Adverse Event Rate | Posted | Count of Participants | Participants | 12 month follow-up |
|
|
|
| Secondary | Acute Procedure Success | Posted | Number | 95% Confidence Interval | percentage of participants | Upon completion of the index procedure, up to ten hours |
|
|
|
| Secondary | Absence of Atrial Fibrillation | Absence of atrial fibrillation after the 3 month blanking period through twelve month follow-up based on auto trigger event monitor. | Denominators are subjects who are evaluable for secondary efficacy endpoint. | Posted | Count of Participants | Participants | After the 3 month blanking period through twelve month follow-up. |
|
|
|
| Secondary | Number of Participants With Reintervention to Address Atrial Dysrhythmia | Number of Participants with Reintervention to Address Atrial Dysrhythmia, through 12 months | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Participants With DC Cardioversion | Not Posted | 12 months | Participants |
| Secondary | Improvement in AF | Improvement in Atrial Fibrillation Symptom Checklist Frequency (Minimum value: -1.0, Maximum value: 25.0) and Severity Scores (Minimum value: -6.0, Maximum value: 19.0) | Denominators are subjects who are evaluable for secondary efficacy endpoint. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | Duration of Procedure | Denominators are subjects who are evaluable for secondary efficacy endpoint. | Posted | Mean | Standard Deviation | Hours | During index procedure |
|
|
|
| 16 |
| 24 |
| 20 |
| 24 |
| Cardiac Perforation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Wound Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Embolic Stroke - Epicardial Ablation Procedure | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Vocal Cord Paresis | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Mediastinal Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Atrial Fibrillation - Other Relationship | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial Flutter - Other Relationship | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ventricular Fibrillation - Other Relationship | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Visual Impairment | Eye disorders | MedDRA | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Implantable Defribrillator Malfunction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Intervertebral Disc Degeneration | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Alcohol Withdrawal Syndrome | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Ischaemia | Vascular disorders | MedDRA | Systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac Perforation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Wound Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cardiac Vein Perforation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Embolic Stroke - Epicardial Ablation Procedure | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Vocal Cord Paresis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Mouth Ulceration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Postoperative Ileus | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Mediastinal Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Anaemia - Other Relationship | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial Flutter - Other Relationship | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrioventricular Block | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ventricular Fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Visual Impairment | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Chest Pains | General disorders | MedDRA | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Implantable Defribillator Malfunction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Ulnar Nerve Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Intervertebral Disc Degeneration | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Essential Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Alcohol Withdrawal Syndrome | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Ischaemia | Vascular disorders | MedDRA | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
|
| Atrial Fibrillation |
|
| Atrial Flutter |
|
| Atrial Tachycardia |
|
| Failure by both AAD and Holter/Pacemaker Interrog |
|
| MI |
|
| Cardiac Tamponade |
|
| Pulmonary Embolism |
|
| Peripheral Embolism |
|
| Atrio-esophageal Fistula |
|
| Diaphragmatic Paralysis |
|
| Pulmonary Vein Stenosis |
|
| New 2nd/3rd Degree AV Block Requiring PPM |
|
| Serious Skin Burns |
|
| Conversion to Thoracotomy or Sternotomy |
|
| Catheter Related SAEs |
|
| Surgical Procedure Related SAEs |
|
| Measurements |
|---|
|
| Inferior Left Pulmonary Veins Isolation Achieved |
|
| Superior Right Pulmonary Veins Isolation Evaluated |
|
| Superior Right Pulmonary Veins Isolation Achieved |
|
| Superior Left Pulmonary Veins Isolation Evaluated |
|
| Superior Left Pulmonary Veins Isolation Achieved |
|
| Left Atrium Posterior Box Isolation Evaluated |
|
| Left Atrium Posterior Box Isolation Achieved |
|
| Bi-drectional block Mitral Valve Isthmus Evaluated |
|
| Bi-drectional block Mitral Valve Isthmus Achieved |
|
| Bi-directional block of RC isthmus evaluated |
|
| Bi-directional block of RC isthmus achieved |
|
| Superior Vena Cava block evaluated |
|
| Superior Vena Cava block achieved |
|
|
| Efficacy Evaluable at 12 Months |
|
|
| Free of AF independent of the need for AADs at 12M |
|
|
|
| Title | Measurements |
|---|---|
|
| EP Catheter Procedure Time |
|
|