Clinical trial NCT06166277: Cardioneuroablation for Recurrent Vasovagal Syncope and Bradyarrhythmias: The CNA-FWRD Registry
Official title: Cardioneuroablation for the Management of Patients With Recurrent Vasovagal Syncope and Symptomatic Bradyarrhythmias: The CNA-FWRD Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vasovagal Syncope
AV Block-2Nd Degree-Type 1
Sinus Pause
Keywords: vasovagal syncope
av block
sinus pause
pacemaker
cardioneuroablation
radiofrequency ablation
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with vasovagal syncope or symptomatic bradyarrhythmia

Brief summary: The CNA-FWRD Registry is an international prospective observational multicenter registry of patients with symptomatic vasovagal syncope and bradyarrhythmias managed under routine care by medical therapy and radiofrequency catheter ablation of ganglionated plexi or permanent pacemaker implantation.

Detailed description: The CNA-FWRD Registry is an international prospective observational multicenter registry of patients with symptomatic vasovagal syncope and bradyarrhythmias managed under routine care by medical therapy and radiofrequency catheter ablation of ganglionated plexi or permanent pacemaker implantation. Major inclusion criteria for enrollment are history of VVS or symptomatic bradyarrhythmia, age \< 60 years, and evaluation by a physician and discussion about potential candidacy for radiofrequency cardioneuroablation or permanent pacemaker implantation for medically refractory symptoms.

For analysis purposes, patients awaiting the intervention will remain in the "control group" and will cross-over to the "procedural group" after successful completion of radiofrequency cardioneuroablation procedure. The follow-up for the procedure group will start at completion of CNA procedure, but patients who eventually do not get the procedure will stay in the control group until the end of the study, with similar follow-up performed as for the patients undergoing RFCA procedure. If a patient in the control group undergoes permanent pacemaker placement, then the day after the procedure the patient will be removed from the control group for follow up.

Eligibility criteria: Inclusion Criteria:

* symptomatic vasovagal syncope or symptomatic bradyarrhythmia refractory to behavioral and medical measures
* age \< 60 years

Exclusion Criteria:

* age \> 60 years
* intra-/infra-Hisian AV block
* intrinsic sinus node disease
* history of supraventricular tachycardia
* history of ventricular tachycardia
* presence of structural heart disease related
* prior history of catheter ablation
* presence of inheritable arrhythmic conditions
* orthostatic hypotension on HUTT test
* abnormal thyroid function levels
* Proven indication for permanent pacemaker implantation

Primary outcomes:
measure: Syncope
timeFrame: 3 years
Secondary outcomes:
measure: Time to first syncopal recurrence
timeFrame: 3 years
measure: Syncope burden
timeFrame: 3 years
measure: Presyncope burden
timeFrame: 3 years
measure: Ablation induced change in heart rate
timeFrame: 1 year
measure: Complications associated with GP ablation
timeFrame: 1 year
measure: Quality of life before and 12 months after ablation
timeFrame: 1 year
measure: Redo-ablation procedures
timeFrame: 3 years
measure: Atrial arrhythmias
timeFrame: 3 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Centert
state: Illinois
Study officials:
affiliation: Yepedite University
name: Tolga Aksu, MD
role: STUDY_CHAIR
References:
citation: Pachon JC, Pachon EI, Pachon JC, Lobo TJ, Pachon MZ, Vargas RN, Jatene AD. "Cardioneuroablation"--new treatment for neurocardiogenic syncope, functional AV block and sinus dysfunction using catheter RF-ablation. Europace. 2005 Jan;7(1):1-13. doi: 10.1016/j.eupc.2004.10.003.
citation: Pachon JC, Pachon EI, Cunha Pachon MZ, Lobo TJ, Pachon JC, Santillana TG. Catheter ablation of severe neurally meditated reflex (neurocardiogenic or vasovagal) syncope: cardioneuroablation long-term results. Europace. 2011 Sep;13(9):1231-42. doi: 10.1093/europace/eur163. Epub 2011 Jun 28.
citation: Scanavacca M, Hachul D. Ganglionated Plexi Ablation to Treat Patients with Refractory Neurally Mediated Syncope and Severe Vagal-Induced Bradycardia. Arq Bras Cardiol. 2019 Jul 15;112(6):709-712. doi: 10.5935/abc.20190107. No abstract available.
citation: Aksu T, Gopinathannair R, Bozyel S, Yalin K, Gupta D. Cardioneuroablation for Treatment of Atrioventricular Block. Circ Arrhythm Electrophysiol. 2021 Sep;14(9):e010018. doi: 10.1161/CIRCEP.121.010018. Epub 2021 Sep 1.
citation: Piotrowski R, Baran J, Sikorska A, Krynski T, Kulakowski P. Cardioneuroablation for Reflex Syncope: Efficacy and Effects on Autonomic Cardiac Regulation-A Prospective Randomized Trial. JACC Clin Electrophysiol. 2023 Jan;9(1):85-95. doi: 10.1016/j.jacep.2022.08.011. Epub 2022 Aug 28.