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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, RFA versus RFA plus botulinum toxin injection, in patients with supra-ventricular tachyarrhythmias. Results were assessed with the use of an implanted monitoring device (IMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFA | Active Comparator | Mapping and radiofrequency ablation are performed by using standard methods. |
|
| RFA+BT injection | Active Comparator | Mapping and radiofrequency ablation are performed by using standard methods. Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiofrequency ablation | Procedure |
| ||
| botulinum toxin injection |
| Measure | Description | Time Frame |
|---|---|---|
| number of episodes of atrial fibrillation | 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 | 11528 | United States | |
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| Label | URL |
|---|---|
| State Research Institute of Circulation Pathology Official Site | View source |
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| Drug |
|
| State Research Institute of Circulation Pathology |
| Recruiting |
| Novosibirsk |
| 630055 |
| Russia |
|
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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