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to assess the near-term (12 months) efficacy of pulmonary vein isolation.
The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein isolation using a standard approach compared to application of an additional acute procedural endpoint of unexcitability along the ablation line.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loss of pace capture | Active Comparator | Pulmonary vein isolation: Ablation along the ablation line is continued until loss of pace capture along the ablation line is achieved catheter based pulmonary vein isolation |
|
| Conventional | Active Comparator | Pulmonary vein isolation: Ablation is discontinued when electrical isolation of the pulmonary veins is achieved. catheter based pulmonary vein isolation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| catheter based pulmonary vein isolation | Device | catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| time to AF and AT recurrence | recurrence of AF as assessed by 3 day holter monitoring, assessment of AT recurrence using 3 day holter monitoring | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| procedure duration | time needed to complete the procedure | completed (15 months) |
| procedure safety | complication such as groin hematoma, stroke and pericardial bleed prolonging the hospital stay will be assessed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Willems | Universitäres Herzzentrum Hamburg GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hamburg | Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23644091 | Derived | Steven D, Sultan A, Reddy V, Luker J, Altenburg M, Hoffmann B, Rostock T, Servatius H, Stevenson WG, Willems S, Michaud GF. Benefit of pulmonary vein isolation guided by loss of pace capture on the ablation line: results from a prospective 2-center randomized trial. J Am Coll Cardiol. 2013 Jul 2;62(1):44-50. doi: 10.1016/j.jacc.2013.03.059. Epub 2013 May 1. |
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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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Open Label
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| up to three days after the procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |