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| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
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Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of Radiofrequency Ablation of Atrial Fibrillation
Atrial fibrillation is the most common rhythm disturbance affecting the human population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | The study arm group will have the ICE catheter placed through one of two existing 8F sheaths already in the left atrium. The ICE catheter will be exchanged in the sheath utilizing the lasso multipolar mapping catheter during left pulmonary vein ablation lines. During exchange, suction and irrigation techniques will be utilized to avoid any air or thrombus embolization. All patients will have standard anticoagulation during the procedure with heparin infusion adjusted to an activated clotting time (ACT) of 350-400. The left sided ICE catheter will be adjusted to visualize left sided structures, ablation tip and tissue interface, and adjacent noncardiac structures such as the esophagus during radiofrequency ablation of the left pulmonary vein system. |
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| Control arm | Active Comparator | The control arm group will receive standard pulmonary vein isolation (PVI) procedure utilizing intracardiac guided ultrasound (ICE) placed within the right atrium via the femoral vein. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biosense Webster irrigated tip catheter | Device | The second group (study group) will have the ICE catheter placed through one of two existing 8F sheaths already in the left atrium. The ICE catheter will be exchanged in the sheath utilizing the lasso multipolar mapping catheter during left pulmonary vein ablation lines. During exchange, suction and irrigation techniques will be utilized to avoid any air or thrombus embolization. All patients will have standard anticoagulation during the procedure with heparin infusion adjusted to an activated clotting time (ACT) of 350-400. The left sided ICE catheter will be adjusted to visualize left sided structures, ablation tip and tissue interface, and adjacent noncardiac structures such as the esophagus during radiofrequency ablation of the left pulmonary vein system. |
| Measure | Description | Time Frame |
|---|---|---|
| number of lesions requiring ablation to obtain Electrical Isolation PV System | to assess the number of lesions requiring ablation to obtain Electrical Isolation PV system | during procedure |
| Measure | Description | Time Frame |
|---|---|---|
| to assess number of lesions to obtain Electrical Isolation PV system | Evaluate the time required to obtain electrical isolation of PV system | during procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety-Cardiac perforation, emboli, fistula formation | evaluate the use of ultrasound catheter for adverse events such as cardiac perforation, emboli or fistula formation | during procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Jones, MD | Wellmont CVA Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellmont CVA Heart Institute | Kingsport | Tennessee | 37660 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 1, 2019 | |
| Reset | May 24, 2019 | |
| Release | May 18, 2020 |
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|
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| Biosense Webster irrigated tip catheter | Device | Group 1 will receive standard pulmonary vein isolation (PVI) procedure utilizing intracardiac guided ultrasound (ICE) placed within the right atrium via the femoral vein. |
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| Pulmonary vein isolation | Procedure |
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| ICE catheter placed through one of two existing 8F sheaths | Procedure |
|
| Reset | Jun 1, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 1, 2019 | May 24, 2019 | |||
| May 18, 2020 | Jun 1, 2020 |
| 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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