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

NCT06166277 | Recruiting DMC

• 1 other identifier: CNA-FWRD
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Vasovagal Syncope; AV Block-2Nd Degree-Type 1; Sinus Pause

Keywords

vasovagal syncope; av block; sinus pause; pacemaker; cardioneuroablation; radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• Syncope

  Recurrent syncope

  3 years

Secondary Outcomes (8)

• Time to first syncopal recurrence

  3 years

• Syncope burden

  3 years

• Presyncope burden

  3 years

• Ablation induced change in heart rate

  1 year

• Complications associated with GP ablation

  1 year

Study Arms (2)

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

Interventions

Ablation procedure PROCEDURE

Cardioneuroablation procedure or permanent pacemaker placement

Also known as: Permanent pacemaker placement

Procedural group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with vasovagal syncope or symptomatic bradyarrhythmia

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Centert

Chicago, Illinois, 60657, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 15670960 RESULT

• 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.

  PMID: 21712276 RESULT

• 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.

  PMID: 31314822 RESULT

• 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.

  PMID: 34465122 RESULT

• 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.

  PMID: 36114133 RESULT

MeSH Terms

Conditions

Syncope, Vasovagal; Atrial Standstill; Atrioventricular Block

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes

Study Officials

• Tolga Aksu, MD

  Yepedite University

  STUDY CHAIR

Central Study Contacts

Alexander Mazur, MD

CONTACT

312-942-5020; alexander_mazur@rush.edu

Jeanne du Fay de Lavallaz, MD

CONTACT

312-942-5000; jeanne.dufaydelavallaz@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)