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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The primary objective is to assess any differences in patient quality of life between Cryo Balloon ablation and Radiofrequency ablation in the treatment of atrial fibrillation. The study will also assess any differences in the amount and duration of pain medication required after the ablation.
Currently there are several different accepted techniques for performing ablation of atrial fibrillation. The two primary techniques currently in use in our center for atrial fibrillation are Cryo Balloon and Radiofrequency ablation.
Based on personal observation, it is felt that patients undergoing Radiofrequency ablation have a higher incidence of chest discomfort and subsequently a greater requirement for pain medications post procedure as compared to those patients undergoing Cryo ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryo Balloon Ablation | Arctic Front Advance Cryo Balloon: Mode of ablation determined based on patient and physician preference | ||
| Radiofrequency Ablation | Contact Force Sensing Radiofrequency Catheter Ablation: Mode of ablation determined based on patient and physician preference |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Measurement | Self report pain intensity measured at baseline and then once a day beginning at least four hours after the ablation. Three individual pain scales will be used. Universal Pain Assessment Tool is scored 0 to 10 with 0 = no pain and 10 = severe. | 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Health Status and Activity Measurement | Self report health status and activity measured at baseline and then once a day beginning at least four hours after the ablation using SF-36 Health and Well-Being Questionnaire. | 7 Days |
| Pain Medication Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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Cardiology
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Manager | Contact | 850-484-6690 | Jennifer.Lehmann@bhcpns.org |
| Name | Affiliation | Role |
|---|---|---|
| Sumit Verma, MD | Cardiology Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Consultants | Recruiting | Pensacola | Florida | 32501 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 22, 2021 | |
| Reset | Jan 28, 2022 | |
| Release | Mar 7, 2022 | |
| Reset | May 27, 2022 | |
| Release | Mar 16, 2023 | |
| Reset | Dec 13, 2023 | |
| Release | Dec 18, 2023 | |
| Reset | May 30, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 22, 2021 | Jan 28, 2022 | |||
| Mar 7, 2022 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Assess amount and duration of pain medication required post ablation |
| 30 Days |
| May 27, 2022 |
| Mar 16, 2023 | Dec 13, 2023 |
| Dec 18, 2023 | May 30, 2024 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |