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Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy compared to second choice after failed medical therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoballoon ablation | Experimental | Cryoballoon ablation |
|
| Cryoballoon after medical therapy | Active Comparator | Cryoballoon ablation |
|
| Cryoballoon as first-line therapy | Experimental | Cryoballoon ablation |
|
| Cryoballoon after failed drug therapy | Active Comparator | Cryoballoon ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoballoon ablation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite) | At prespecified interval of 12th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring | 12 months from the procedure |
| Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite) | At prespecified interval of 3rd month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring | 3 months from the procedure |
| Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite) | At prespecified interval of 6th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring | 6 months from the procedure |
| Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite) | At prespecified interval of 9th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring | 9 months from the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuksek Ihtisas Heart-Education and Research Hospital | Ankara | 06100 | Turkey (Türkiye) |
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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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| D013568 |
| Pathological Conditions, Signs and Symptoms |