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Logistical problems
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Treatment of (long-standing) persistent atrial fibrillation (AF) remains cumbersome and the surgical (epicardial) approach seems to be the most effective. Still, however a significant amount of failures exist which is mostly due to incompleteness of the surgical ablation lines. Checking, and if necessary additional ablation, of these lines afterwards endocardially by the cardiologist (the so-called serial hybrid approach) could overcome this problem.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epicardial (surgical) ablation | Active Comparator | Epicardial Pulmonary vein isolation |
|
| Hybrid | Experimental | Epicardial (surgical) ablation & Endocardial assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epicardial (surgical) ablation | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation Freedom | left sided atrial flutter and left atrial tachycardia | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| re-isolation | number of pulmonary veins needing re-isolation by the EP | 8-10 weeks |
| Percentage of cross-over | Percentage of cross-over from the surgical arm alone to surgery and serial hybrid ablation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jurren van Opstal, MD PhD | Medisch Spectrum Twente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medisch Spectrum Twente | Enschede | Overijssel | 7500AB | Netherlands |
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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 |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Hybrid | Procedure | Epicardial (surgical) ablation
Endocardial assessment after 6-8 weeks, checking for isolation and if necessary touch up by RF ablation |
|
| 1 year |
| Complications | Number of complications and thrombo-embolic events in both groups | 1 year |
| Atrial fibrillation Burden | Burden of AF in both groups if AF is still present. | 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |