Cardiac Autonomic Denervation for Cardio-inhibitory Syncope

Not Applicable

Not yet recruiting

• Conditions: Syncope, Vasovagal; Bradycardia; Syncope
• Interventions: Procedure: Electrophysiological study; Procedure: Electrophysiological study and Right side Ganglionated Plexi ablation; Procedure: Electrophysiological study and bi-atrial Ganglionated Plexi ablation

• Registration Number: NCT05572034
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-07
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-18
• Study Start: 2023-09-01
• Primary Completion: 2023-12-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Electrophysiological study	A diagnostic electrophysiological study will be performed in patients of group A
Group B	Electrophysiological study and Right side Ganglionated Plexi ablation	A electrophysiological study with cardiac denervation, with right Ganglionated Plexi ablation exclusively will be performed in patients of group B
Group C	Electrophysiological study and bi-atrial Ganglionated Plexi ablation	A electrophysiological study with cardiac denervation, with right and left Ganglionated Plexi ablation will be performed in patients of group C.

Primary Outcome Measures

Name	Time	Method
recurrence of syncope	24 months	To compare the recurrence of syncope or pre-syncope and a negative tilt test with the different techniques of electrophysiological procedures currently used.

Secondary Outcome Measures

Name	Time	Method
electrocardiographic and electrophysiological parameters	24 months	Compare the following electrocardiographic and electrophysiological parameters of vagal attenuation: * Heart rate (bpm - beats per minute); * Internal AH (represents AV internodal conduction time, with normal values between 50-120 ms); * Wenckebach cycle; * Presence of Holter pauses 30 days after the intervention.

Trial Locations

Locations (2)

University of Sao Paulo General Hospital; 🇧🇷 Sao Paulo, SP, Brazil

Arrhythmia and electrophysiology of the Heart Institute - University of São Paulo; 🇧🇷 São Paulo, Brazil