An observational study in Vasovagal Syncope, AV Block-2Nd Degree-Type 1 and Sinus Pause, sponsored by Rush University Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by Rush University Medical Center · Observational
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.
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.
88 studies on the registry are indexed under Syncope, Vasovagal; 28 are open to participants now.
This study's planned enrollment of 300 is above the median of 140 across 29 observational studies indexed under Syncope, Vasovagal.
Browse Syncope, Vasovagal studies →Rush University Medical Center is the lead sponsor of 397 studies on the registry; 61 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with vasovagal syncope or symptomatic bradyarrhythmia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Awaiting the intervention, medically managed patients will remain in the control group for analysis purposes
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
Also known as: Permanent pacemaker placement
Syncope
Recurrent syncope
Time frame: 3 years
Time to first syncopal recurrence
Time to first syncope episode since enrollment
Time frame: 3 years
Syncope burden
Number of syncopal episodes
Time frame: 3 years
Presyncope burden
Number of pre syncopal episodes
Time frame: 3 years
Ablation induced change in heart rate
Delta change in HR between pre-ablation and post-ablation
Time frame: 1 year
Complications associated with GP ablation
Major peri-procedural complications
Time frame: 1 year
Quality of life before and 12 months after ablation
QoL assessed by survey
Time frame: 1 year
Redo-ablation procedures
Redo-ablation procedures for primary outcomes
Time frame: 3 years
Atrial arrhythmias
Development of new atrial arrhythmias
Time frame: 3 years
Plan to share: No
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