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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2027-04-30

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.

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

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

No interventions assigned to this group

Procedural group

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

Ablation procedure

Intervention Type PROCEDURE

Cardioneuroablation procedure or permanent pacemaker placement

Interventions

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Ablation procedure

Cardioneuroablation procedure or permanent pacemaker placement

Intervention Type PROCEDURE

Other Intervention Names

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Permanent pacemaker placement

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No