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This prospective, acute, first-in-human, non-significant risk study is intended to evaluate a modified version of the ViewFlex X ICE Catheter, Sensor Enabled (ViewFlex X SE) and ViewMate Multi Ultrasound Console (VMM) ICE data integration with the EnSite X EP System (hereafter referred to as the ViewFlex X ICE System).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Single Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System |
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| Cohort 2 | Single Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System |
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| Cohort 3 | Single Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ViewFlex X ICE System | Device | Subjects to undergo cardiac ablation procedure utilizing the ViewFlex X ICE System |
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| Measure | Description | Time Frame |
|---|---|---|
| Physician assessment of the ability to navigate the ViewFlex X SE catheter and adequately visualize major cardiac anatomic structures. | During the procedure | |
| Physician assessment of the ability to use anatomic ICE markers and ICE geometry as a reference during mapping and ablation procedures. | during the procedure | |
| Rate of device- or procedure-related serious adverse events that occur through patient discharge. | during the procedure and periprocedurally |
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Inclusion Criteria:
A patient will be eligible for clinical trial participation if they meet the following criteria:
Exclusion Criteria:
A patient will be excluded from enrollment in the study if they meet any of the following criteria:
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This clinical investigation will enroll subjects of all genders over the age of 18 undergoing any previously planned electrophysiology study procedure utilizing ICE.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ben Gansemer, PhD | Contact | 9527152719 | benjamin.gansemer@abbott.com | |
| Amber Miller, PhD | Contact | amber.miller@abbott.com |
| Name | Affiliation | Role |
|---|---|---|
| Kristin Ruffner, PhD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Bernards Medical Center | Recruiting | Jonesboro | Arkansas | 72401 | United States |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| University of California, San Diego | Recruiting | La Jolla | California | 92037 | United States |
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| Ascension St. Vincent's Riverside | Recruiting | Jacksonville | Florida | 32204 | United States |
| Research Medical Center | Recruiting | Kansas City | Missouri | 64132 | United States |
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| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
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