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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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The MAP-AF study will compare RHYTHMIA vs CARTO in redo ablation of paroxysmal AF with assessment of both acute procedural profiles and clinical outcomes.
Pulmonary venous conduction recovery is found in most patients undergoing redo ablation procedures for atrial fibrillation (AF). Identifying gaps in prior ablation lines is essential to achieve successful outcomes. High density mapping systems have been proposed to allow the identification of such gaps with speed and accuracy.
The MAP-AF study will compare RHYTHMIA vs CARTO in redo ablation of paroxysmal AF with assessment of both acute procedural profiles and clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mapping with CARTO | CARTO (Biosense Webster) in conjunction with CONFIDENSE mapping module and PENTARRAY catheter |
| |
| Mapping with RHYTHMIA | RHYTHMIA (Boston Scientific) in conjunction with the 64-electrodes ORION mini-basket catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CARTO | Device | Redo-ablation of paroxysmal AF with high density mapping system, CARTO, in conjunction with CONFIDENSE mapping module and PENTARRAY catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| System is able to accurately identify gaps | Incidence of accurate identification of gaps in prior ablation lines by the system | At the time of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment success | Freedom from AF recurrence | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Electrophysiology clinic patients who are considered candidates for redo paroxysmal AF ablation.
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| Name | Affiliation | Role |
|---|---|---|
| Ayman Hussein, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | 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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| RHYTHMIA | Device | Redo-ablation of paroxysmal AF with high density mapping system, RHYTHMIA, in conjunction with the 64-electrodes ORION mini-basket catheter. |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |