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The purpose of this study is to confirm the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact in the treatment of atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeartLight Ablation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopically Guided Ablation | Device | Visually Guided Ablation using EAS-AC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Isolation of Pulmonary Veins. | 99% of pulmonary veins were isolated (72/73) | Acute PVI measured on the day of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Burke Barrett | CardioFocus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Cardiologico Monzino | Milan | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | HeartLight Ablation | Pulmonary Vein Isolation with the HeartLight System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HeartLight Ablation | Pulmonary Vein Isolation with the HeartLight System. Participants with data available are reported so that not all measures may include data from 20 participants. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Full Range | years |
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| Gender | Number | participants with data available |
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| 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 | Acute Isolation of Pulmonary Veins. | 99% of pulmonary veins were isolated (72/73) | All treated participants with reported data. | Posted | Number | percent isolated pulmonary veins | Acute PVI measured on the day of treatment |
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Acute, peri-procedural assessment of adverse events.
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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 | HeartLight Ablation | Pulmonary Vein Isolation with the HeartLight System | 1 | 20 | 0 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
|
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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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