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NCT Number: NCT06166277

Cardioneuroablation for Recurrent Vasovagal Syncope and 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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ablation procedure

Procedure

Cardioneuroablation procedure or permanent pacemaker placement

Other names: Permanent pacemaker placement

Primary outcomes

  1. Syncope

    Time frame: 3 years

    Recurrent syncope

Secondary outcomes

  1. Time to first syncopal recurrence

    Time frame: 3 years

    Time to first syncope episode since enrollment

  2. Syncope burden

    Time frame: 3 years

    Number of syncopal episodes

  3. Presyncope burden

    Time frame: 3 years

    Number of pre syncopal episodes

  4. Ablation induced change in heart rate

    Time frame: 1 year

    Delta change in HR between pre-ablation and post-ablation

  5. Complications associated with GP ablation

    Time frame: 1 year

    Major peri-procedural complications

  6. Quality of life before and 12 months after ablation

    Time frame: 1 year

    QoL assessed by survey

  7. Redo-ablation procedures

    Time frame: 3 years

    Redo-ablation procedures for primary outcomes

  8. Atrial arrhythmias

    Time frame: 3 years

    Development of new atrial arrhythmias

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Mazur, MD

CONTACT

[email protected]

312-942-5020

Jeanne du Fay de Lavallaz, MD

CONTACT

[email protected]

312-942-5000

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Acronym: CNA-FWRD

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 12, 2023
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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