Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction

Summary

Endocardial ganglion plexus ablation (cardioneuroablation) represents a promising therapeutic technique for the treatment of vasovagal syncope (VV), functional atrioventricular block (AVB) and sinus node dysfunction (SND) with a component of vagal hypertonia. Nevertheless, there is currently a paucity of literature about the results according to the type of presentation (VV, AVB or SND). The investigators aim to assess the safety and efficacy of cardioneuroablation for the treatment of symptomatic SND.

Conditions

• Sinus Node Dysfunction
• Sick Sinus Syndrome

Interventions

PROCEDURE

Cardioneuroablation

After 3D mapping of the surface of the left and right atrium and the superior vena cava (Ensite Navx, Carto), localization of ganglion plexus (GP) will be performed either anatomically and/or by means of high frequency stimulation (HFS). The anterior and superior right sided GP will always be ablated per protocol. Other GP will be ablated according to interventional electrophysiologist judgement. The endpoint of the ablation procedure will be 1) absence of a vagal response after HFS from the right jugular vein and 2) an increase in at least 10 bpm as compared to baseline.

DEVICE

Permanent dual chamber pacemaker implantation

Under local anesthesia and using a subclavian or cephalic vein approach a dual chamber pacemaker implantation with a lead in the right atrium and a lead in the right ventricle will be performed. The device will be programmed in a AAI-DDDR mode to avoid unnecessary ventricular pacing.

Sponsors & Collaborators

• Spanish Society of Cardiology

  collaborator OTHER

• Hospital Universitario Lucus Augusti

  collaborator OTHER

• Hospital Clinico Universitario de Santiago

  lead OTHER

Principal Investigators

• Carlos Minguito Carazo, MD · Hospital Clinico Universitario de Santiago

• Moises Rodríguez Mañero, PhD · Hospital Clinico Universitario de Santiago

• Jose Ramón González Juanatey, PhD · Hospital Clinico Universitario de Santiago

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-01

Primary Completion

2023-11-01

Completion

2023-11-01

Countries

• Spain

Study Locations