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This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with HeartLight System | Experimental | Treatment of paroxysmal atrial fibrillation (PAF) with HeartLight System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioFocus HeartLight Endoscopic Ablation System | Device | PVI ablation |
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| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Recurrence of Atrial Fibrillation | Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Burke Barret | CardioFocus, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Pacific Heart Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With EAS-AC | Treatment of PAF with EAS-AC CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC): PVI ablation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Santa Monica |
| California |
| 90404 |
| United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48072 | United States |
| Mt. Sinai Hospital | New York | New York | 10029 | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| The Methodist Hospital Research Institute | Houston | Texas | 77030 | United States |
| University Of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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100 participants were enrolled in the study. 86 participants that met all inclusion/exclusion criteria received treatment with the HeartLight System and are included in the reported results.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With HeartLight | Treatment of PAF with HeartLight System PVI ablation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Freedom From Recurrence of Atrial Fibrillation | Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period. | Primary Effectiveness Endpoint participants. Of the 86 enrolled and treated participants, 84 were evaluable for the effectiveness endpoint. | Posted | Number | successful participants | 12 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 | Treatment With HeartLight | Treatment of PAF with HeartLight | 14 | 86 | 23 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac perforation, pericardial effusion, tamponade | Cardiac disorders | Systematic Assessment | Participants may have more than one reported AE. |
| |
| Pericarditis | Cardiac disorders | Systematic Assessment | Participants may have more than one reported AE. |
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| Phrenic nerve injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | Participants may have more than one reported AE. |
| |
| Death, unrelated to investigational device | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain/discomfort | Cardiac disorders |
| |||
| Pericarditis | Cardiac disorders |
| |||
| Phrenic nerve injury | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Burke Barrett, VP Regulatory & Clinical Affairs | CardioFocus, Inc. | 508 658-7200 | bbarrett@cardiofocus.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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