Cardioneuroablation for Recurrent Vasovagal Syncope and Bradyarrhythmias: The CNA-FWRD Registry

Vasovagal Syncope Clinical Trial

— CNA-FWRD  

Official title:

Cardioneuroablation for the Management of Patients With Recurrent Vasovagal Syncope and Symptomatic Bradyarrhythmias: The CNA-FWRD Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06166277
• Other study ID #: CNA-FWRD
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: February 2024
• Source: Rush University Medical Center
• Contact: Henry Huang, MD
• Phone: 972-951-5317
• Email: henry_d_huang[@]rush.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: April 30, 2027
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrioventricular Block
• Bradycardia
• Syncope
• Syncope, Vasovagal
• Vasovagal Syncope

Intervention

Procedure:
• Ablation procedure
Cardioneuroablation procedure or permanent pacemaker placement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

References & Publications (5)

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. — View 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/ — View 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/ — View 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.20 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Syncope	Recurrent syncope	3 years
Secondary	Time to first syncopal recurrence	Time to first syncope episode since enrollment	3 years
Secondary	Syncope burden	Number of syncopal episodes	3 years
Secondary	Presyncope burden	Number of pre syncopal episodes	3 years
Secondary	Ablation induced change in heart rate	Delta change in HR between pre-ablation and post-ablation	1 year
Secondary	Complications associated with GP ablation	Major peri-procedural complications	1 year
Secondary	Quality of life before and 12 months after ablation	QoL assessed by survey	1 year
Secondary	Redo-ablation procedures	Redo-ablation procedures for primary outcomes	3 years
Secondary	Atrial arrhythmias	Development of new atrial arrhythmias	3 years