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

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Completed; Phase 2

Conditions: Hypertension; Atrial Fibrillation

Treatments: Procedure: PVI + GP ablation; Procedure: PVI+renal denervation; Drug: Optimal medial therapy (OMT)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01898910

RDGP-031

Details and patient eligibility

About

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).

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

PVI+renal denervation+OMT

Active Comparator group

Treatment:

Procedure: PVI+renal denervation

Drug: Optimal medial therapy (OMT)

PVI+GP ablation+OMT

Active Comparator group

Treatment:

Procedure: PVI + GP ablation

Drug: Optimal medial therapy (OMT)