Clinical trial NCT05186220: Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction
Official title: Endocardial Ablation of Ganglionated Plexi Versus Pacemaker Implantation in Patients With Symptomatic Sinus Node Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sinus Node Dysfunction
Sick Sinus Syndrome
Keywords: cardioneuroablation
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
Collaborators: name: Spanish Society of Cardiology
name: Hospital Universitario Lucus Augusti
First posted: 2022-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Sinus node dysfunction (SND), also known as sick sinus syndrome, comprises a wide spectrum of sinoatrial dysfunctions, ranging from sinus bradycardia, sinoatrial block, and sinus arrest to bradycardia tachycardia syndrome. An additional manifestation of SND is an inadequate chronotropic response to exercise, reported as chronotropic incompetence. Since the first cardiac denervation was reported in 2005, several registries and retrospective studies using this therapeutic approach for reflex syncope, SND and functional atrioventricular block have been published. However, due to the lack of randomized studies, current guidelines recommend permanent pacemaker implantation for patients with symptomatic SND in order to improve symptoms. Therefore, the purpose of the present study is to assess the safety and efficacy of cardioneuroablation versus permanent pacemaker implantation for the treatment of symptomatic SND.

This is a multicenter, randomized, open, interventional study. After being informed of the study and potential risks, participants will undergo a one week screening period to determine eligibility for the study entry. During this week, participants will undergo an exercise test, atropine test, and a 24 hour-holter electrocardiogram. Then, participants who meet the eligibility criteria, will be randomized 1:1 to receive permanent pacemaker implantation (control group) or cardioneuroablation (interventional group).

The primary endpoint (improve in quality of life assessed with 36-Item Short Form Survey (SF-36)) will be evaluated at six months since randomization.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline in the SF-36 Health Survey of quality of life
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: 6 month free survival from permanent pacemaker implantation in the interventional group (cardioneuroablation)
timeFrame: Baseline and 6 months
measure: Change in maximal heart rate and chronotropic incompetence in the exercise test
timeFrame: Baseline and 6 months
measure: Differences in complications rates between both gropus
timeFrame: Baseline and 6 months
measure: Differences in 6 month free survival from syncope between both groups
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
state: A Coruña
Study officials:
affiliation: Hospital Clinico Universitario de Santiago
name: Carlos Minguito Carazo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinico Universitario de Santiago
name: Moises Rodríguez Mañero, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Clinico Universitario de Santiago
name: Jose Ramón González Juanatey, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.