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

Rush

Status: Enrolling

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

Treatments: Procedure: Ablation procedure

Study type: Observational

Funder types: Other

Identifiers

NCT06166277

CNA-FWRD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Control group

Description:

Awaiting the intervention, medically managed patients will remain in the control group for analysis purposes

Procedural group

Description:

After undergoing successful radiofrequency cardioneuroablation or permanent pacemaker procedures the patient will cross-over to the procedural group for analysis purposes

Treatment:

Procedure: Ablation procedure