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This is a prospective randomized controlled trial that compares the conventional stepwise approach with a new sequential substrate ablation approach for persistent atrial fibrillation.
A total number of 100 patients with persistent AF were randomized to receive either conventional stepwise ablation (conventional group) or a sequential substrate ablation (substrate group), both with the endpoint of AF termination. All patients were in AF before the procedure. The sequential substrate ablation consisted of pulmonary vein isolation (PVI) followed by cardioversion and linear ablation at the mitral isthmus, left atrial roof and cavotricuspid isthmus in order to modify the AF substrate. After achievement of bidirectional block, AF was re-induced and electrogram-based ablation was performed to achieve AF termination to sinus rhythm (SR). Endpoints are single-procedure outcome and total amount of RF ablation time required to terminate AF by electrogram-guided ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: stepwise ablation | Other | Stepwise ablation of persistent atrial fibrillation (conventional treatment arm) In this arm, patients will be treated with the conventional stepwiese ablation approach |
|
| Group B: sequential substrate ablation | Active Comparator | Sequential substrate ablation of persistent atrial fibrillation (novel procedure) In this arm, patients will undergo an ablation procedure that consist of PVI, cardioversion, linear ablation and atrial fibrillation re-induction after blocked lines, followed by electrogram-guided ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation | Procedure | In both arms, patients will undergo an ablation procedure for persistent atrial fibrillation. The sequence of ablation steps are different between both arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients without any arrhythmias during follow-up of 12 months | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Rostock, MD | University Hospital Mainz, Department of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Mainz, Department of Medicine II | Mainz | 55131 | Germany |
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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 |