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

Recruiting

• Conditions: Sinus Pause; Vasovagal Syncope; AV Block-2Nd Degree-Type 1
• Interventions: Procedure: Ablation procedure

• Registration Number: NCT06166277
• Lead Sponsor: Rush University Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-12
• Study Start: 2024-08-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Primary Completion: 2026-12-31
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Procedural group	Ablation procedure	After undergoing successful radiofrequency cardioneuroablation or permanent pacemaker procedures the patient will cross-over to the procedural group for analysis purposes

Primary Outcome Measures

Name	Time	Method
Syncope	3 years	Recurrent syncope

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rush University Medical Centert; 🇺🇸 Chicago, Illinois, United States