Recruiting

Observational Study

Sponsor:

Rush University Medical Center

Code:

NCT06166277

Conditions

Vasovagal Syncope

AV Block-2Nd Degree-Type 1

Sinus Pause

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Ablation procedure

Study Details

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.

Conditions

Vasovagal Syncope

AV Block-2Nd Degree-Type 1

Sinus Pause

Study ID

NCT06166277

Start date

Aug 1, 2024

Status verified date

Sep, 2025

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Control group

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

Procedural group

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

Interventions

Ablation procedure

Cardioneuroablation procedure or permanent pacemaker placement

Primary outcome measure

  • Syncope [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Alexander Mazur, MD

312-942-5020alexander_mazur@rush.edu

Jeanne du Fay de Lavallaz, MD

312-942-5000jeanne.dufaydelavallaz@gmail.com

Locations

Rush University Medical Centert

Recruiting

Chicago, Illinois, United States, 60657

Contacts

Henry D Huang, MD

312-942-5020henry_d_huang@rush.edu

More Information

Sponsor

Rush University Medical Center

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

Keywords

  • vasovagal syncope
  • av block
  • sinus pause
  • pacemaker
  • cardioneuroablation
  • radiofrequency ablation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2025-09-18.