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

NCT05186220 | Unknown

• 1 other identifier: 2021/307
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cardioneuroablation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the SF-36 Health Survey of quality of life

  The SF-36 Health Survey is a validated, well known generic test for assessment of the health-related quality of life of patients.

  Baseline and 6 months

Secondary Outcomes (4)

• 6 month free survival from permanent pacemaker implantation in the interventional group (cardioneuroablation)

  Baseline and 6 months

• Change in maximal heart rate and chronotropic incompetence in the exercise test

  Baseline and 6 months

• Differences in complications rates between both gropus

  Baseline and 6 months

• Differences in 6 month free survival from syncope between both groups

  Baseline and 6 months

Study Arms (2)

Cardioneuroablation

EXPERIMENTAL

After 3D mapping of the surface of the left and right atrium and the superior vena cava (Ensite Navx or Carto system), 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.

Procedure: Cardioneuroablation

Permanent pacemaker implantation

ACTIVE COMPARATOR

A dual chamber pacemaker implantation will be performed. The device will be programmed in a AAI-DDDR mode to avoid unnecessary ventricular pacing.

Device: Permanent dual chamber pacemaker implantation

Interventions

Cardioneuroablation PROCEDURE

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.

Also known as: Endocardial ganglion plexus ablation

Cardioneuroablation

Permanent dual chamber pacemaker implantation DEVICE

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.

Permanent pacemaker implantation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic sinus node dysfunction (dizziness, asthenia or syncope) clearly related to an abnormal electrocardiogram finding (sinus arrest, sinoatrial block, extreme bradycardia (\<40 bpm) or chronotropic incompetence in the exercise test).
• Absence of structural cardiopathy

You may not qualify if:

• Left ventricular ejection fraction \<50%
• Severe valvular disease
• Any type of cardiomyopathy such as hypertrophic cardiomyopathy
• Previous ischemic heart disease
• QRS interval \>130 ms
• Atrioventricular conduction disorder with a former indication of pacemaker implantation (atrioventricular block Mobitz II, advanced atrioventricular block, complete atrioventricular block)
• Lifetime expectance \<12 months

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead
• Spanish Society of Cardiology: collaborator
• Hospital Universitario Lucus Augusti: collaborator

Study Sites (1)

Hospital Clinico Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

RECRUITING

Related Publications (3)

• Pachon-M JC, Pachon-M EI, Pachon CTC, Santillana-P TG, Lobo TJ, Pachon-M JC, Zerpa-A JC, Cunha-P MZ, Higuti C, Ortencio FA, Amarante RC, Silva RF, Osorio TG. Long-Term Evaluation of the Vagal Denervation by Cardioneuroablation Using Holter and Heart Rate Variability. Circ Arrhythm Electrophysiol. 2020 Dec;13(12):e008703. doi: 10.1161/CIRCEP.120.008703. Epub 2020 Nov 16.

  PMID: 33198486 BACKGROUND

• Hu F, Zheng L, Liang E, Ding L, Wu L, Chen G, Fan X, Yao Y. Right anterior ganglionated plexus: The primary target of cardioneuroablation? Heart Rhythm. 2019 Oct;16(10):1545-1551. doi: 10.1016/j.hrthm.2019.07.018. Epub 2019 Jul 19.

  PMID: 31330187 BACKGROUND

• Pachon JC, Pachon EI, Cunha Pachon MZ, Lobo TJ, Pachon JC, Santillana TG. Catheter ablation of severe neurally meditated reflex (neurocardiogenic or vasovagal) syncope: cardioneuroablation long-term results. Europace. 2011 Sep;13(9):1231-42. doi: 10.1093/europace/eur163. Epub 2011 Jun 28.

  PMID: 21712276 RESULT

MeSH Terms

Conditions

Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos Minguito Carazo, MD

  Hospital Clinico Universitario de Santiago

  PRINCIPAL INVESTIGATOR

• Moises Rodríguez Mañero, PhD

  Hospital Clinico Universitario de Santiago

  STUDY DIRECTOR

• Jose Ramón González Juanatey, PhD

  Hospital Clinico Universitario de Santiago

  STUDY CHAIR

Central Study Contacts

Carlos Minguito Carazo, MD

CONTACT

981 95 07 93; carlosminguito@hotmail.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Cardiology consultant, Electrophysiology fellow

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 11, 2022
• Study Start: November 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Baseline to 2 years

Locations

ES (1)