An interventional study of Electrophysiological study and Electrophysiological study and Right side Ganglionated Plexi ablation in Bradycardia; Syncope and Syncope, Vasovagal, sponsored by University of Sao Paulo General Hospital. Not yet recruiting at 2 sites in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-18.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
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.
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's planned enrollment of 45 is below the median of 100 across 187 interventional studies indexed under Bradycardia.
Browse Bradycardia studies →University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
A diagnostic electrophysiological study will be performed in patients of group A
Procedure: Electrophysiological study
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
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.
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: 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.
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.
Time frame: 24 months
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.
Time frame: 24 months
Plan to share: No
Start is estimated for Sep 2023; primary completion for Dec 2023, 3 months later.
Of 47 non-industry interventional studies with no phase under Bradycardia, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 59. This study's planned 3 months is below that.
Counting every sponsor, half of 83 studies reached it within 21 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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