Cardiac Autonomic Denervation for Cardio-inhibitory Syncope

NCT05572034 | Unknown DMC

• 1 other identifier: UAP 174
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Bradycardia; Syncope; Syncope, Vasovagal

Keywords

Cardiac denervation; Cardio-inhibitory syncope

Outcome Measures

Primary Outcomes (1)

• recurrence of syncope

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

  24 months

Secondary Outcomes (1)

• electrocardiographic and electrophysiological parameters

  24 months

Study Arms (3)

Group A

SHAM COMPARATOR

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

Procedure: Electrophysiological study

Group B

ACTIVE COMPARATOR

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

Procedure: Electrophysiological study and Right side Ganglionated Plexi ablation

Group C

ACTIVE COMPARATOR

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

Procedure: Electrophysiological study and bi-atrial Ganglionated Plexi ablation

Interventions

Electrophysiological study PROCEDURE

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.

Group A

Electrophysiological study and Right side Ganglionated Plexi ablation PROCEDURE

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.

Group B

Electrophysiological study and bi-atrial Ganglionated Plexi ablation PROCEDURE

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.

Group C

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Abbott: collaborator

Study Sites (2)

University of Sao Paulo General Hospital

São Paulo, São Paulo, 01246-000, Brazil

Location

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

São Paulo, 05403-900, Brazil

Location

Related Publications (2)

• 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.

  PMID: 33024505 BACKGROUND

• 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.

  PMID: 34026520 BACKGROUND

MeSH Terms

Conditions

Bradycardia; Syncope; Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases

Study Officials

• Mauricio I Scanavacca, MD, PhD

  University of Sao Paulo - General Hospítal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauricio I scanavacca, MD, PhD

CONTACT

+ 55 11 26615341; mauricio.scanavacca@incor.usp.br

Esteban W Rivarola, MD, PhD

CONTACT

+55 11 26615341; eteban@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: all patients will go for intervention, however they will not know which group they were randomized to
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of arrhythmia and electrophysiology Unit

Model Details: 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)

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: October 7, 2022
• Study Start: September 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: March 30, 2024
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)