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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vasovagal Syncope; AV Block-2Nd Degree-Type 1; Sinus Pause
• Intervention / Treatment: Procedure: Ablation procedure

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Henry Huang, MD; Phone Number: 972-951-5317; Email: henry_d_huang@rush.edu
• Study Contact Backup: Name: Jeanne du Fay de Lavallaz, MD; Phone Number: 312-942-5000; Email: jeanne.dufaydelavallaz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with vasovagal syncope or symptomatic bradyarrhythmia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; Awaiting the intervention, medically managed patients will remain in the control group for analysis purposes
Procedural group; After undergoing successful radiofrequency cardioneuroablation or permanent pacemaker procedures the patient will cross-over to the procedural group for analysis purposes	Procedure: Ablation procedure; Cardioneuroablation procedure or permanent pacemaker placement; Other Names: Permanent pacemaker placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Syncope	Recurrent syncope	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Study Chair: Tolga Aksu, MD, Yepedite University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: radiofrequency ablation; pacemaker; av block; cardioneuroablation; vasovagal syncope; sinus pause
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Autonomic Nervous System Diseases; Unconsciousness; Consciousness Disorders; Primary Dysautonomias; Orthostatic Intolerance; Heart Block; Bradycardia; Syncope; Syncope, Vasovagal; Atrioventricular Block
• Other Study ID Numbers: CNA-FWRD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No