Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and technical feasibility of treating subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar System, with mapping and additional lesion creation/ gap closure (as needed) provided by currently approved catheter technology, when the epicardial and endocardial phases are performed in a staged manner within 1-10 days apart, during the same hospitalization.
The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery using the AtriCure Bipolar System in conjunction with a catheter ablation procedure performed approximately 1-10 days after, in treating atrial fibrillation, and how effective is this staged procedure. 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AtriCure Bipolar System combined with a catheter ablation | Experimental | Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation procedure staged catheter ablation | Device | AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer. | Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms. | 30 days post-index procedure or hospital discharge |
| Number of Subjects With Absence of Atrial Fibrillation | Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy. | 12 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number Subjects With Serious Device or Procedure Related Adverse Event Rate | 12 month follow-up | |
| Number of Subjects With Acute Procedure Success | Defined as subject meeting all of the following criteria upon completion of the index-EP procedure
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States | ||
| Colorado Springs Cardiology/Colorado Cardiac Alliance |
Five consented subjects were withdrew prior to treatment. Three did not meet the eligibility criteria, 1 subject was withdrawn by the investigator, and 1 subject withdrew consent.
First subject treated on September 11, 2012. A total of 31 subjects consented from 6 sites (4 USA and 2 Europe). One subject was exited from the study prior to intervention and was re-consented. Only 30 unique subjects were enrolled in the study. Twenty-six subjects treated from 5 sites.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AtriCure Bipolar System Combined With a Catheter Ablation | Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Number of Treated Subjects
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AtriCure Bipolar System Combined With a Catheter Ablation | Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart |
| 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 Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer. | Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms. | Number of treated subjects. Although 26 subjects were anesthetized only 25 subjects underwent epicardial procedure per protocol. Physician decided not to treat one of the anesthetized subjects. Another case was aborted and converted to open chest cardioversion. Twenty-four patients underwent endocardial catheter procedures. | Posted | Count of Participants | Participants | 30 days post-index procedure or hospital discharge |
|
24-months
Not provided
Not provided
| 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 | Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Operations | AtriCure, Inc. | 513-755-4562 | SZink@AtriCure.com |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 0 |
| Number of Subject Without Atrial Fibrillation | AF free with or without the need of antiarrhythmic drugs | 6 and 12 month follow-up |
| Number of Subjects With Reinterventions | 12 month follow-up |
| Number of Subjects With Direct Current (DC) Cardioversion | 12 month follow-up |
| Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores | Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline.
| 12 month follow-up |
| Colorado Springs |
| Colorado |
| 80907 |
| United States |
| Vanderbilt Heart Institute | Nashville | Tennessee | 37232 | United States |
| Sentara Norfolk Hospital | Norfolk | Virginia | 23507 | United States |
| Universitair Ziekenhuis Brussel | Brussels | Belgium |
| Academic Medical Center | Amsterdam | Netherlands |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | inches |
|
| Weight | Mean | Standard Deviation | Lbs. |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
|
|
| Primary | Number of Subjects With Absence of Atrial Fibrillation | Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy. | Subjects who are evaluable for primary efficacy endpoint, defined as all subjects in whom the minimally invasive staged epicardial/ endocardial ablation procedure is attempted and in whom the index-EP procedure and required post-procedure and 12 month follow-up efficacy endpoint assessment has been performed. | Posted | Count of Participants | Participants | 12 month follow-up |
|
|
|
| Secondary | Number Subjects With Serious Device or Procedure Related Adverse Event Rate | Posted | Count of Participants | Participants | 12 month follow-up |
|
|
|
| Secondary | Number of Subjects With Acute Procedure Success | Defined as subject meeting all of the following criteria upon completion of the index-EP procedure
| Posted | Count of Participants | Participants | Day 0 |
|
|
|
| Secondary | Number of Subject Without Atrial Fibrillation | AF free with or without the need of antiarrhythmic drugs | Posted | Count of Participants | Participants | 6 and 12 month follow-up |
|
|
|
| Secondary | Number of Subjects With Reinterventions | Posted | Count of Participants | Participants | 12 month follow-up |
|
|
|
| Secondary | Number of Subjects With Direct Current (DC) Cardioversion | Posted | Count of Participants | Participants | 12 month follow-up |
|
|
|
| Secondary | Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores | Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline.
| Posted | Mean | Standard Deviation | percentage of from baseline | 12 month follow-up |
|
|
|
| 12 |
| 26 |
| 16 |
| 26 |
| Atrial tachycardia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Multi-organ failure | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Device lead damage | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Unresponsive to stimuli | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vocal cord paralysis | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diaphragmatic paralysis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ankle operation | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
|
| Heart valve operation | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diaphragmatic paralysis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |