A Phase 2 interventional study of PVI+renal denervation and PVI + GP ablation in Atrial Fibrillation and Hypertension, sponsored by Meshalkin Research Institute of Pathology of Circulation. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-07-15.
Sponsored by Meshalkin Research Institute of Pathology of Circulation · Phase 2, Interventional, and Treatment
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).
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 80 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Meshalkin Research Institute of Pathology of Circulation is the lead sponsor of 114 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Procedure: PVI+renal denervation · Drug: Optimal medial therapy (OMT)
Procedure: PVI + GP ablation · Drug: Optimal medial therapy (OMT)
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.
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).
Antiarrhythmic and antihypertensive therapy will be administered according to the guidelines
Freedom of AF or other atrial arrhythmias
Time frame: 12 months
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Meshalkin Research Institute of Pathology of Circulation