Clinical trial NCT05572034: Cardiac Autonomic Denervation for Cardio-inhibitory Syncope
Official title: Cardiac Autonomic Denervation for Cardio-inhibitory Syncope
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bradycardia; Syncope
Syncope, Vasovagal
Keywords: Cardiac denervation
Cardio-inhibitory syncope
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2022-10-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, prospective, sham controll, on a 1:1:1 basis to group A (Sham - 15 patients); group B (right sided denervation - 15 patients); and group C (bilateral denervation - 15 patients)
Primary purpose: TREATMENT

Brief summary: Background: Autonomic system modification is an established therapeutic approach that has been increasingly used for the treatment of vagal-related symptomatic bradycardia, such as cardio-inhibitory vasovagal syncope1-12.

Although convincing results had been reported from small populations, a large randomized study providing robust evidence on the efficacy of this approach has not yet been performed.

Hypothesis: Cardiac autonomic system modification is effective for the treatment of vagal-related symptomatic bradycardia, and is associated better clinical results as compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 70 years old.
* Cardio-inhibitory response (VASIS 2A or 2B) during tilt test, or after carotid sinus massage.
* Patients with bradycardia mediated by vagal hypertonia documented on 24-hour Holter monitoring and a clear relationship with symptoms.

Exclusion Criteria:

* Ages under 18 and over 70
* Presence of structural heart disease documented by echocardiography.
* Hypothyroidism and hyperthyroidism, drug effects, obstructive sleep apnea and other causes of secondary bradycardia.
* Anatomical disease of the conduction system.

Primary outcomes:
measure: recurrence of syncope
timeFrame: 24 months
Secondary outcomes:
measure: electrocardiographic and electrophysiological parameters
timeFrame: 24 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo General Hospital
state: SP
city: São Paulo
country: Brazil
facility: Arrhythmia and electrophysiology of the Heart Institute - University of São Paulo
Study officials:
affiliation: University of Sao Paulo - General Hospítal
name: Mauricio I Scanavacca, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hardy C, Rivarola E, Scanavacca M. Role of Ganglionated Plexus Ablation in Atrial Fibrillation on the Basis of Supporting Evidence. J Atr Fibrillation. 2020 Jun 30;13(1):2405. doi: 10.4022/jafib.2405. eCollection 2020 Jun-Jul.
citation: Sarabanda AV, Melo SL, Rivarola E, Hachul D, Scanavacca M. Anatomically guided atrial ganglionated plexus ablation evaluated by extracardiac vagal stimulation for vagally mediated atrioventricular block. HeartRhythm Case Rep. 2021 Feb 10;7(5):301-305. doi: 10.1016/j.hrcr.2021.02.002. eCollection 2021 May. No abstract available.