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The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions (LL) plus botulinum toxin injection versus PVI plus linear lesions (LL), in patients with persistent or longstanding persistent AF. Results were assessed with the use of an implanted monitoring device (IMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVI+LL | Active Comparator | Circumferential PVI was accomplished and then additional ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the LA between the two superior PVs (roof). Finally, patients underwent cavo-tricuspid isthmus ablation in the right atrium. |
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| PVI+LL+BT injection | Active Comparator | Circumferential PVI was accomplished and then additional ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the LA between the two superior PVs (roof). Finally, patients underwent cavo-tricuspid isthmus ablation in the right atrium. Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary vein isolation | Procedure |
| ||
| Linear Lesion Ablation |
| Measure | Description | Time Frame |
|---|---|---|
| freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| serious adverse events | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evgeny Pokushalov, MD, PhD | Contact | +79139254858 | e.pokushalov@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Active, not recruiting | Rochester | New York | United States | ||
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| Label | URL |
|---|---|
| State Research Institute of Circulation Pathology Official Site | View source |
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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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| Procedure |
|
| BT injection | Drug |
|
| State Research Institute of Circulation Pathology |
| Recruiting |
| Novosibirsk |
| 630055 |
| Russia |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |