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This study will assess the efficacy of catheter ablation versus the Wolf Mini-Maze surgical ablation for rhythm control in patients with persistent afib.
Higher success rates have been achieved after a single surgical ablation when compared to catheter ablation, however contiguous and transmural lesions are not always guaranteed.
Even though, catheter ablation is now being offered for symptomatic persistent AF, recurrence after the index procedure in such a persistent AF substrate is not unusual. Redo-catheter ablation is routinely offered for such patients; however long term success still remains low. Non-pulmonary vein triggers are often targeted in such redo-catheter ablation procedures; though this approach remains controversial. More recently, the Wolf Mini-Maze procedure has been utilized with promising results.
This study proposes to randomize a group of persistent AF patients to undergo either catheter ablation or the surgical mini-maze procedure with left atrial appendage (LAA) ligation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter Ablation | Active Comparator | Catheter based radiofrequency ablation with wide antral circumferential PVI and isolation of posterior wall will be performed. Mitral and cavo-tricuspid isthmus ablation will be done only if such isthumus dependent flutters are documented prior to / during the procedure. |
|
| Mini-maze surgical procedure | Active Comparator | Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter ablation | Procedure | Catheter based radiofrequency ablation with wide antral circumferential PVI and isolation of posterior wall will be performed. Mitral and cavo-tricuspid isthmus ablation will be done only if such isthumus dependent flutters are documented prior to / during the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who are free from atrial fibrillation (AF) | 12 months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experienced a procedural complication | 2 weeks after the procedure | |
| Number of participants who are at risk of stroke | 12 months after the procedure | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh Venkataraman, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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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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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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|
| Mini-maze surgical procedure | Procedure | Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed. |
|
| Number of participants who were hospitalized for cardiovascular events |
| 12 months after the procedure |
| AF burden as assessed by the CCA-SAF | AF burden will be assessed using the Canadian Cardiovascular Society - Severity of Atrial Fibrillation Score (CCA-SAF), which provides objective symptoms severity scoring. | 12 months after the procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |