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The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different strategies, PVI plus Renal Denervation (RD) versus PVI plus GP ablation, in patients with atrial fibrillation. Results were assessed after follow-up of at least 1 year with the use of an implanted monitoring device (IMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVI+renal denervation+OMT | Active Comparator |
| |
| PVI+GP ablation+OMT | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVI+renal denervation | Procedure | After AF ablation procedure, the angiogram of both renal arteries is performed via femoral access. After that the treatment catheter is introduced into each renal artery and is applied discrete, radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. After the procedure the control arterial angiogram should be done. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom of AF or other atrial arrhythmias | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Research Institute of Circulation Pathology | Novosibirsk | 630055 | Russia |
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| Label | URL |
|---|---|
| State Research Institute of Circulation Pathology Official Site | View source |
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|
| PVI + GP ablation | Procedure | To accomplish ganglionated plexi ablation, LA target sites were identified as the anatomic locations where vagal reflexes were evoked by transcatheter high-frequency stimulation (HFS). Rectangular electrical stimuli were delivered at a frequency of 20-50 Hz, output amplitude 15 V and pulse duration of 10 ms, for 5 sec (Stimulator B-53, Biotok Inc, Russia). |
|
| Optimal medial therapy (OMT) | Drug | Antiarrhythmic and antihypertensive therapy will be administered according to the guidelines |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
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