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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01898910
First received: July 4, 2013
Last updated: July 12, 2013
Last verified: July 2013

July 4, 2013
July 12, 2013
June 2012
June 2013   (final data collection date for primary outcome measure)
Freedom of AF or other atrial arrhythmias [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01898910 on ClinicalTrials.gov Archive Site
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Ganglionated Plexi Ablation vs Renal Denervation in Patients Undergoing Pulmonary Vein Isolation
Ganglionated Plexi Ablation vs Renal Denervation in Patients Undergoing Pulmonary Vein Isolation. A Randomized Comparison

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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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Hypertension
  • Procedure: PVI+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.
  • Procedure: PVI + 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).
  • Drug: Optimal medial therapy (OMT)
    Antiarrhythmic and antihypertensive therapy will be administered according to the guidelines
  • Active Comparator: PVI+renal denervation+OMT
    Interventions:
    • Procedure: PVI+renal denervation
    • Drug: Optimal medial therapy (OMT)
  • Active Comparator: PVI+GP ablation+OMT
    Interventions:
    • Procedure: PVI + GP ablation
    • Drug: Optimal medial therapy (OMT)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01898910
RDGP-031
Yes
Meshalkin Research Institute of Pathology of Circulation
Meshalkin Research Institute of Pathology of Circulation
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Meshalkin Research Institute of Pathology of Circulation
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP