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Pulmonary vein isolation (PVI) is currently the cornerstone non pharmacological therapy for drug-refractory atrial fibrillation (AF). Where rhythm control has been shown to be inferior as compared to rate control in older trials. New data suggest that for patients with heart failure and AF PVI may improve prognosis (mortality) as compared to medical rate or rhythm control. Whether optimal rate control as can be achieved with atrioventricular node ablation is comparable with regard to all-cause mortality of heart failure hospitalization to PVI in patients with heart failure and AF is unknown.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary vein isolation | Active Comparator | Ablation of the pulmonary veins. |
|
| atrioventricular node ablation. | Active Comparator | Ablation of the atrioventricular node. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation | Procedure | Ablation of either the pulmonary veins or the atrioventricular node |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death. | Occurence of all-cause death. | 1 year |
| cardiovascular hospitalization. | Occurence of cardiovascular hospitalization (heart failure or stroke). | 1 year |
| Quality of life | Change in quality of life (using the Kansas City Cardiomyopathy Questionnaire (KCCQ)). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Death from any cause | Occurence of death from any cause. | 1 year |
| Unplanned hospitalization | Occurence of unplanned hospitalization related to heart failure. |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9700VB | Netherlands |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 1 year |
| death from cardiovascular disease | Occurence of death from cardiovascular disease. | 1 year |
| cerebrovascular accident. | Occurence of stroke. | 1 year |
| unplanned hospitalization for cardiovascular disease | Any unplanned hospitalization for cardiovascular disease. | 1 year |
| Any hospitaliation | Any hospitalization for non-cardiovascular disease. | 1 year |
| changes in the Kansas city cardiomyopathy questionnaire | Changes in quality of life (any) | 1 year |
| procedure related adverse events | Occurence of procedure related adverse events. | 1 year |
| atrial fibrillation-free intervals were assessed. | Assessment of AF free intervals. | 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |