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

Phase 2

Completed

• Conditions: Atrial Fibrillation; Hypertension
• Interventions: Procedure: PVI+renal denervation; Procedure: PVI + GP ablation; Drug: Optimal medial therapy (OMT)

• Registration Number: NCT01898910
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-07
• Study First Submitted: 2013-07-04
• Study First Submitted QC: 2013-07-12
• Last Update Submitted: 2013-07-12
• Study First Posted: 2013-07-15
• Last Update Posted: 2013-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI+renal denervation+OMT	PVI+renal denervation	-
PVI+renal denervation+OMT	Optimal medial therapy (OMT)	-
PVI+GP ablation+OMT	PVI + GP ablation	-
PVI+GP ablation+OMT	Optimal medial therapy (OMT)	-

Primary Outcome Measures

Name	Time	Method
Freedom of AF or other atrial arrhythmias	12 months

Trial Locations

Locations (1)

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation