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

Last updated: October 2, 2024
Sponsor: Rush University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arrhythmia

Heart Defect

Orthostatic Hypotension

Treatment

Ablation procedure

Clinical Study ID

NCT06166277
CNA-FWRD
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • symptomatic vasovagal syncope or symptomatic bradyarrhythmia refractory tobehavioral and medical measures

  • age < 60 years

Exclusion

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 Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Ablation procedure
Phase:
Study Start date:
August 01, 2024
Estimated Completion Date:
April 30, 2027

Study 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.

Connect with a study center

  • Rush University Medical Centert

    Chicago, Illinois 60657
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.