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Patients did not want to be randomized in their procedure.
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There is a need to compare the efficacy of PVI versus PVI plus catheter ablation, which includes ablation of complex fractionated atrial electrograms (CFAE) and linear lesions in the same procedure. If it is found that the PVI alone is as effective as PVI plus catheter ablation of CFAE and linear lesions, it may reduce the need for catheter ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVI Plus Catheter Ablation | Active Comparator | Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF. |
|
| PVI Alone | Active Comparator | Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVI Plus Catheter Ablation | Procedure | Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to recurrence | Any atrial fibrillation/atrial tachycardia/atrial flutter following the blanking period. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recurrence following intervention | Time to recurrence following intervention | 12 months post intervention |
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Inclusion Criteria:
(Step 1 - Registration)
(Step 2 - Randomization)
Exclusion Criteria:
(Step 1 - Registration)
(Step 2 Randomization)
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| Name | Affiliation | Role |
|---|---|---|
| Jasbir Sra, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora Health Care | Milwaukee | Wisconsin | 53215 | United States |
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| PVI Alone | Procedure | Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF. |
|
| 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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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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