Bradycardia; SyncopeCardioSyncNCT05572034
Cardiac Autonomic Denervation for Cardio-inhibitory Syncope
A study testing Electrophysiological study, Electrophysiological study and Right side Ganglionated Plexi ablation and Electrophysiological study and bi-atrial Ganglionated Plexi ablation in people with Bradycardia; Syncope and Syncope, Vasovagal, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bradycardia; Syncope, Syncope, Vasovagal
- What is being tested?
- Electrophysiological study, Electrophysiological study and Right side Ganglionated Plexi ablation and Electrophysiological study and bi-atrial Ganglionated Plexi ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Sep 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Brazil2 sites
University of Sao Paulo General Hospital
São Paulo, São Paulo, 01246-000
Mauricio I Scanavacca, MD, PhD, +551126615341, mauricio.scanavacca@gmail.com
Esteban W Rivarola, MD, PhD, +551126615341, eteban@hotmail.com
Arrhythmia and electrophysiology of the Heart Institute - University of São Paulo
São Paulo, 05403-900
Gabrielle D Pessente, BSc, MS, +55 11 26615712, gabrielle.pessente@hc.fm.usp.br
Esteban W Rivarola, MD, PhD
About this study
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
- Being tested
- Electrophysiological study, Electrophysiological study and Right side Ganglionated Plexi ablation, Electrophysiological study and bi-atrial Ganglionated Plexi ablation
- Keywords
- Cardiac denervation, Cardio-inhibitory syncope
- Medical subject headings
- Bradycardia, Syncope, Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiological studyProcedure or surgery
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.
Electrophysiological study and Right side Ganglionated Plexi ablationProcedure or surgery
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.
Electrophysiological study and bi-atrial Ganglionated Plexi ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Sham comparator | A diagnostic electrophysiological study will be performed in patients of group A Receives: 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 Receives: 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. Receives: Procedure: Electrophysiological study and bi-atrial Ganglionated Plexi ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
electrocardiographic and electrophysiological parameters
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Sep 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bradycardia; SyncopeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Mauricio Ibrahim Scanavacca, University of Sao Paulo General Hospital
- Investigators
- Mauricio I Scanavacca, MD, PhD, Principal investigator, University of Sao Paulo - General Hospítal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572034
- Sponsor's protocol ID
- UAP 174
- Acronym
- CardioSync
- Status last verified
- Aug 2023
- First submitted
- 20 May 2022
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33024505Sarabanda 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.
PubMed 34026520
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Autonomic Denervation for Cardio-inhibitory Syncope
- ClinicalTrials.gov ID
- NCT05572034
- Acronym / sponsor ID
- CardioSync / UAP 174
- Conditions
- Bradycardia; Syncope, Syncope, Vasovagal
- Keywords
- Cardiac denervation, Cardio-inhibitory syncope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Group A | Sham comparator | Procedure: Electrophysiological studyA diagnostic electrophysiological study will be performed in patients of group A |
| Group B | Active comparator | Procedure: Electrophysiological study and Right side Ganglionated Plexi ablationA electrophysiological study with cardiac denervation, with right Ganglionated Plexi ablation exclusively will be performed in patients of group B |
| Group C | Active comparator | Procedure: Electrophysiological study and bi-atrial Ganglionated Plexi ablationA electrophysiological study with cardiac denervation, with right and left Ganglionated Plexi ablation will be performed in patients of group C. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrophysiological studyElectrophysiological 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 or surgery | Group A |
| Electrophysiological study and Right side Ganglionated Plexi ablationElectrophysiological 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 or surgery | Group B |
| Electrophysiological study and bi-atrial Ganglionated Plexi ablationElectrophysiological 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. | Procedure or surgery | Group C |
Primary outcome
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.
1 secondary outcome
electrocardiographic and electrophysiological parameters
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Background: PubMed 33024505Hardy 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.
- Background: PubMed 34026520Sarabanda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauricio I Scanavacca, MD, PhD principal investigator
University of Sao Paulo - General Hospítal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrophysiological study, Electrophysiological study and Right side Ganglionated Plexi ablation and Electrophysiological study and bi-atrial Ganglionated Plexi ablation in people with Bradycardia; Syncope and Syncope, Vasovagal, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mauricio I scanavacca, MD, PhD (+ 55 11 26615341, mauricio.scanavacca@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of syncope (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05572034, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.