UnknownNot Applicable

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

Spain40 participantsStarted 2021-11-01

Plain-language 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.

Who can participate

Age range40 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Baseline and 6 months

Trial details

NCT IDNCT05186220

SponsorHospital Clinico Universitario de Santiago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-01

Contact for this trial

Carlos Minguito Carazo, MD

981 95 07 93 carlosminguito@hotmail.es