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Recruiting NCT06166277

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ablation procedure.
Who it may be relevant to
Registry conditions: Vasovagal Syncope, AV Block-2Nd Degree-Type 1, Sinus Pause. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Ablation procedure
    Cardioneuroablation procedure or permanent pacemaker placement

Primary outcome measures

  • Syncope [Time frame: 3 years]
Secondary outcome measures (8)
  • Time to first syncopal recurrence [Time frame: 3 years]
  • Syncope burden [Time frame: 3 years]
  • Presyncope burden [Time frame: 3 years]
  • Ablation induced change in heart rate [Time frame: 1 year]
  • Complications associated with GP ablation [Time frame: 1 year]
  • Quality of life before and 12 months after ablation [Time frame: 1 year]
  • Redo-ablation procedures [Time frame: 3 years]
  • Atrial arrhythmias [Time frame: 3 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-crossover

Study locations

United States · 1 center
  • Rush University Medical Centert — Chicago

Publications

  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06166277 · CNA-FWRD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗