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| Name | Class |
|---|---|
| Technische Universität Dresden | OTHER |
| Medical University of Vienna | OTHER |
| Medical University of Lublin | OTHER |
| Elisabethinen Hospital |
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This study evaluates if the exclusion of left atrial low voltage areas / scars by ablation lines in addition to pulmonary vein isolation may improve the outcome in patients with persistent atrial fibrillation in comparison to stand alone pulmonary vein isolation.
This is a prospective, randomized multi center study comparing two catheter ablation strategies (pulmonary vein isolation (PVI) versus PVI plus low voltage areas (LVA) guided for ablation in patients with symptomatic persistent and long standing persistent atrial fibrillation (AF) who were unresponsive to at least one Class I or III antiarrhythmic agents, or it is the patient´s decision to receive ablation as first line therapy. Patients with documented persistent AF who are eligible for participation in the study, and gave a written informed consent, will be randomized between two groups prior to the procedure: PVI and PVI+LVAs guided radiofrequency catheter ablation.
All the patients will receive a high density voltage map in sinus rhythm (SR). All the patients will receive circumferential PVI. If LVAs are present, Patients randomized to the PVI+LVA group will get additional linear ablation lines to exclude these areas from normal voltage atrial myocardium. The patients will be followed for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pulmonary vein isolation alone | Active Comparator | patients randomized to this group receive stand alone pulmonary vein isolation regardless to their left atrial voltage map |
|
| pulmonary vein isolation + low voltage area guided ablation | Experimental | patients randomized to this group receive pulmonary vein isolation + low voltage area guided linear substrate modification in the case if there are any |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiofrequency ablation | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| recurrence of atrial arrhythmia | recurrence of the first symptomatic or asymptomatic episode of atrial arrhythmia within 12 months after single catheter ablation procedure, with three-month blanking | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Efficacy Endpoint | recurrence of the first symptomatic or asymptomatic episode of atrial arrhythmia within 12 months after single catheter ablation procedure, with three-month blanking, on implanted cardiac monitors exclusively | 12 months |
| Secondary Safety Endpoint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Piorkowski, MD | Heart Center Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moedling Hospital | Mödling | Lower Austria | 2340 | Austria | ||
| Elisabethinen Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38319851 | Derived | Huo Y, Gaspar T, Schonbauer R, Wojcik M, Fiedler L, Roithinger FX, Martinek M, Purerfellner H, Kirstein B, Richter U, Ulbrich S, Mayer J, Krahnefeld O, Agdirlioglu T, Zedda A, Piorkowski J, Piorkowski C. Low-Voltage Myocardium-Guided Ablation Trial of Persistent Atrial Fibrillation. NEJM Evid. 2022 Nov;1(11):EVIDoa2200141. doi: 10.1056/EVIDoa2200141. Epub 2022 Oct 19. |
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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 |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| OTHER |
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occurrence of one or more of the following adverse events within 90 days from ablation: cardiac tamponade/hemopericardium/effusion, pericarditis, stroke/TIA/arterial embolism, pulmonary vein stenosis, atrioesophageal fistula, septicemia, internal bleeding, phrenic nerve palsy, femoral vascular access complication, death |
| 90 days |
| Linz |
| Upper Austria |
| 4020 |
| Austria |
| Landesklinikum Wiener Neustadt | Vienna | Austria |
| Heart Center Dresden | Dresden | Saxony | 01307 | Germany |
| Sana Kliniken Lübeck | Lübeck | Germany |
| Medical University of Lublin | Lublin | Poland |
| D013568 |
| Pathological Conditions, Signs and Symptoms |