Atrial Fibrillation, Hypertension
Conditions
Brief summary
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).
Interventions
PROCEDUREPVI+renal denervation
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.
PROCEDUREPVI + GP ablation
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).
DRUGOptimal medial therapy (OMT)
Antiarrhythmic and antihypertensive therapy will be administered according to the guidelines
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom of AF or other atrial arrhythmias | 12 months |
Countries
Russia
Outcome results
None listed