Cardiac Autonomic Denervation for Cardio-inhibitory Syncope (CardioSync)

University of Sao Paulo General Hospital

Status: Not yet enrolling

Conditions: Syncope, Vasovagal; Bradycardia; Syncope

Treatments: Procedure: Electrophysiological study and bi-atrial Ganglionated Plexi ablation; Procedure: Electrophysiological study and Right side Ganglionated Plexi ablation; Procedure: Electrophysiological study

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05572034

UAP 174

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Group A

Sham Comparator group

Description:

A diagnostic electrophysiological study will be performed in patients of group A

Treatment:

Procedure: Electrophysiological study

Group B

Active Comparator group

Description:

A electrophysiological study with cardiac denervation, with right Ganglionated Plexi ablation exclusively will be performed in patients of group B

Treatment:

Procedure: Electrophysiological study and Right side Ganglionated Plexi ablation

Group C

Active Comparator group

Description:

A electrophysiological study with cardiac denervation, with right and left Ganglionated Plexi ablation will be performed in patients of group C.

Treatment:

Procedure: Electrophysiological study and bi-atrial Ganglionated Plexi ablation