Cardiac Autonomic Denervation for Cardio-inhibitory Syncope

NAUnknownINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

September 1, 2023

Primary Completion Date

December 30, 2023

Study Completion Date

March 30, 2024

Conditions
Bradycardia; SyncopeSyncope, Vasovagal
Interventions
PROCEDURE

Electrophysiological study

Electrophysiological study: patients in a fasting state and under total intravenous anesthesia Intracardiacelectrogramsare displayed simultaneously on a multichannel recorder. Programmed atrial and ventricular stimulation are performed to rule out sustained arrhythmias, primary conduction system dysfunction, and sick sinus syndrome.

PROCEDURE

Electrophysiological study and Right side Ganglionated Plexi ablation

"Electrophysiological study: patients in a fasting state and under total intravenous anesthesia Intracardiacelectrogramsare displayed simultaneously on a multichannel recorder. Programmed atrial and ventricular stimulation are performed to rule out sustained arrhythmias, primary conduction system dysfunction, and sick sinus syndrome.~GP Mapping and Cardiac denervation: Specific atrium sites are empirically identified as GP by presumed anatomic location based on previous works (anatomic mapping):~In the RA: the posterior aspect of the interatrial septum, between the posterior wall and coronary sinus ostium; and, the septal aspect of the superior vena cava junction (opposite to the LA GP tags).~A 3.5-mm irrigated tip catheter will be used to deliver radiofrequency energy (50°C, 20-30 W, for 30-60 seconds) with a 17 mL/min irrigation flow."

PROCEDURE

Electrophysiological study and bi-atrial Ganglionated Plexi ablation

"Electrophysiological study: patients in a fasting state and under total intravenous anesthesia Intracardiacelectrogramsare displayed simultaneously on a multichannel recorder. Programmed atrial and ventricular stimulation are performed to rule out sustained arrhythmias, primary conduction system dysfunction, and sick sinus syndrome.~GP Mapping and Cardiac denervation: Specific atrium sites are empirically identified as GP by presumed anatomic location based on previous works(anatomic mapping):~In the LA: the inferior right GP (septal aspect of the right pulmonary veins \[PV\]) antra, and LA posterior wall. In the RA: the posterior aspect of the interatrial septum, between the posterior wall and coronary sinus ostium; and the septal aspect of the superior vena cava junction (opposite to the LA GP tags).~A 3.5-mm irrigated tip catheter will be used to deliver radiofrequency energy (50°C, 20-30 W, for 30-60 seconds) with a 17 mL/min irrigation flow."

Trial Locations (2)

01246-000

University of Sao Paulo General Hospital, São Paulo

05403-900

Arrhythmia and electrophysiology of the Heart Institute - University of São Paulo, São Paulo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Abbott

INDUSTRY

lead

University of Sao Paulo General Hospital

OTHER