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| Name | Class |
|---|---|
| CardioFocus | INDUSTRY |
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This protocol aims at assessing the efficacy of performing catheter ablation for atrial fibrillation (AF) with laser catheters versus performing it with radiofrequency (RF) catheters. In order to study laser catheter ablation efficacy, MRI analysis of the lesions 3 months after the procedure will be performed in both groups. MRI analysis will detect ablation gaps in the lesions encircling pulmonary veins. The primary endpoint will compare the number of gaps in the laser catheter and the RF group. The secondary endpoint of the study is recurrence of AF after 12 months. The target population of the study is patients with paroxysmal or persistent AF undergoing AF ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser ablation | Other | Ablation with laser catheter |
|
| RF ablation | Other | Ablation with RF catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser ablation | Device | Pulmonary vein isolation using the laser ablation catheter |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of large gaps in the delayed enhancement MRI (DE-MRI) | The presence of MRI ablation gaps around the pulmonary veins evaluated with MRI images of the patient acquired three months after the ablation procedure. A large gap is described as a GAP that is larger or equal than 20% of the vein perimeter. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the number of patients that present atrial fibrillation after the ablation procedure | The number of patients that present a recurrence in their atrial fibrillation after the ablation procedure during the first year. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic de Barcelona | Barcelona | Catalonia | 08028 | Spain |
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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 |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| RF ablation |
| Device |
Pulmonary vein isolation using the RF ablation catheter |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |