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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Ablation procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>Awaiting the intervention, medically managed patients will remain in the control group for analysis purposes | |
| Procedural group<br>After undergoing successful radiofrequency cardioneuroablation or permanent pacemaker procedures the patient will cross-over to the procedural group for analysis purposes | Procedure: Ablation procedure<br>* Cardioneuroablation procedure or permanent pacemaker placement<br>* Other names: Permanent pacemaker placement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Syncope | Recurrent syncope | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first syncopal recurrence | Time to first syncope episode since enrollment | 3 years | 
| Syncope burden | Number of syncopal episodes | 3 years | 
| Presyncope burden | Number of pre syncopal episodes | 3 years | 
| Ablation induced change in heart rate | Delta change in HR between pre-ablation and post-ablation | 1 year | 
| Complications associated with GP ablation | Major peri-procedural complications | 1 year | 
| Quality of life before and 12 months after ablation | QoL assessed by survey | 1 year | 
| Redo-ablation procedures | Redo-ablation procedures for primary outcomes | 3 years | 
| Atrial arrhythmias | Development of new atrial arrhythmias | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardioneuroablation, radiofrequency ablation, vasovagal syncope, av block, sinus pause, pacemaker