Cardiac Autonomic Denervation for Cardio-inhibitory Syncope
NCT ID: NCT05572034
Last Updated: 2023-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
45 participants
INTERVENTIONAL
2023-09-01
2024-03-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A
A diagnostic electrophysiological study will be performed in patients of group A
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.
Group B
A electrophysiological study with cardiac denervation, with right Ganglionated Plexi ablation exclusively will be performed in patients of group B
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.
Group C
A electrophysiological study with cardiac denervation, with right and left Ganglionated Plexi ablation will be performed in patients of group C.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
University of Sao Paulo General Hospital
OTHER
Responsible Party
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Mauricio Ibrahim Scanavacca
Director of arrhythmia and electrophysiology Unit
Principal Investigators
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Mauricio I Scanavacca, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo - General Hospítal
Locations
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University of Sao Paulo General Hospital
São Paulo, São Paulo, Brazil
Arrhythmia and electrophysiology of the Heart Institute - University of São Paulo
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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UAP 174
Identifier Type: -
Identifier Source: org_study_id
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