Ganglionated Plexi Ablation vs Renal Denervation in Patients Undergoing Pulmonary Vein Isolation

Study Overview
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Brief Summary
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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).

Official Title
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Ganglionated Plexi Ablation vs Renal Denervation in Patients Undergoing Pulmonary Vein Isolation. A Randomized Comparison

Conditions
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Atrial Fibrillation, Hypertension

Intervention / Treatment
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* Procedure: PVI+renal denervation
* Procedure: PVI + GP ablation
* Drug: Optimal medial therapy (OMT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic drug-refractory AF (with history of failure of ≥ 2 class I or III antiarrhythmic drugs) in patients referred for catheter ablation of AF PAF with ≥1 monthly episodes or PersAF in patients who had already undergone ≥3 electrical cardioversions. PAF was defined as episodes lasting less than 7 days with spontaneous termination. PersAF was defined as lasting more than 7 days before being terminated pharmacologically or by electrical cardioversion. History of significant hypertension (defined as SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg), receiving treatment with at least one antihypertensive medication A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula Exclusion Criteria: Previous atrial fibrillation ablation Type 1 of diabetes mellitus Structural heart disease Secondary cause of atrial hypertension Severe renal artery stenosis or renal arteries abnormalities Previous operations on renal arteries Pregnancy Previous heart, kidney, liver, or lung transplantation Unwillingness of participant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVI+renal denervation+OMT<br> | Procedure: PVI+renal denervation<br>* 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.<br>Drug: Optimal medial therapy (OMT)<br>* Antiarrhythmic and antihypertensive therapy will be administered according to the guidelines<br>|
| Active Comparator: PVI+GP ablation+OMT<br> | Procedure: PVI + GP ablation<br>* 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).<br>Drug: Optimal medial therapy (OMT)<br>* Antiarrhythmic and antihypertensive therapy will be administered according to the guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom of AF or other atrial arrhythmias |  | 12 months |