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The purpose of this study is to determine the safety and effectiveness of the endoscopic ablation system - adaptive contact (EAS-AC) in treated paroxysmal atrial fibrillation (PAF) with pulmonary vein isolation (PVI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EAS-AC | Experimental | PVI with EAS-AC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioFocus EAS-AC | Device | PVI for PAF |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardioangiologisches Centrum Bethanien - CCB | Frankfurg | 60431 | Germany | |||
| St. Georg Hosptial |
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| ID | Title | Description |
|---|---|---|
| FG000 | EAS-AC | PVI with EAS-AC CardioFocus EAS-AC: PVI for PAF |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of the 81 enrolled participants, 72 meet all enrollment criteria and were treated. These are the evaluable baseline participants
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| ID | Title | Description |
|---|---|---|
| BG000 | EAS-AC | PVI with EAS-AC CardioFocus EAS-AC: PVI for PAF |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period. | Of the 72 enrolled and treated participants, 67 were evaluable for the chronic 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 | EAS-AC | PVI with EAS-AC CardioFocus EAS-AC: PVI for PAF |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Phrenic nerve injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Burke T. Barrett | CardioFocus, Inc | 508 658-7200 | bbarrett@cardiofocus.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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| Hamburg |
| 20099 |
| Germany |
| Universität Leipzig - Herzzentrum | Leipzig | 04289 | Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 10 |
| 72 |
| 0 |
| 72 |
| Air embolism | Cardiac disorders | Systematic Assessment |
|
| Pericardial tamponade | Cardiac disorders | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |