Cardiac Autonomic Denervation for Cardio-inhibitory Syncope (CardioSync)

August 15, 2023 updated by: Mauricio Ibrahim Scanavacca, University of Sao Paulo General Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Esteban W Rivarola, MD, PhD
  • Phone Number: +55 11 26615341
  • Email: eteban@hotmail.com

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-900
        • Arrhythmia and electrophysiology of the Heart Institute - University of São Paulo
        • Principal Investigator:
          • Maurício I Scanavacca, MD, PhD
        • Sub-Investigator:
          • Esteban W Rivarola, MD, PhD
        • Contact:
    • SP
      • Sao Paulo, SP, Brazil, 01246-000
        • University of Sao Paulo General Hospital
        • Principal Investigator:
          • Maurício I Scanavacca, MD, PhD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Esteban W Rivarola, MD, PhD
        • Sub-Investigator:
          • Gabrielle D Pessente, BsC, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Group A
A diagnostic electrophysiological study will be performed in patients of group A
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.
Active Comparator: Group B
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

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.
Active Comparator: Group C
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence of syncope
Time Frame: 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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
electrocardiographic and electrophysiological parameters
Time Frame: 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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Abbott

Investigators

  • Principal Investigator: Mauricio I Scanavacca, MD, PhD, University of São Paulo - General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

March 30, 2024

Study Registration Dates

First Submitted

May 20, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAP 174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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