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).

Study Overview

• Status: Completed
• Conditions: Hypertension; Atrial Fibrillation
• Intervention / Treatment: Procedure: PVI+renal denervation; Drug: Optimal medial therapy (OMT); Procedure: PVI + GP ablation

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • State Research Institute of Circulation Pathology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation

Publications and helpful links

Helpful Links

• State Research Institute of Circulation Pathology Official Site

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 4, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (Estimate): July 15, 2013

Study Record Updates

• Last Update Posted (Estimate): July 15, 2013
• Last Update Submitted That Met QC Criteria: July 12, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: RDGP-031