Registry for patients with recurrent vasovagal syncope and bradyarrhythmias
Cardioneuroablation for the Management of Patients With Recurrent Vasovagal Syncope and Symptomatic Bradyarrhythmias: The CNA-FWRD Registry
Rush University Medical Center · NCT06166277
This study is tracking how well different treatments work for people under 60 who have ongoing fainting spells and slow heart rates that don't get better with usual care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Rush University Medical Center (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06166277 on ClinicalTrials.gov |
What this trial studies
The CNA-FWRD Registry is an international prospective observational multicenter registry that focuses on patients experiencing symptomatic vasovagal syncope and bradyarrhythmias. Participants are managed through routine care, which may include medical therapy, radiofrequency catheter ablation of ganglionated plexi, or permanent pacemaker implantation. Eligible patients are under 60 years old and have symptoms that are refractory to standard treatments. The study will track outcomes for those undergoing procedures as well as those in a control group awaiting intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals under 60 years old with symptomatic vasovagal syncope or bradyarrhythmia that has not responded to behavioral and medical measures.
Not a fit: Patients over 60 years old or those with specific heart conditions such as intrinsic sinus node disease or structural heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could improve treatment strategies for patients suffering from recurrent vasovagal syncope and bradyarrhythmias.
How similar studies have performed: Other studies have shown promise with similar approaches, particularly in the management of vasovagal syncope and bradyarrhythmias.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois
- Rush University Medical Centert — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Study coordinator: Alexander Mazur, MD
- Email: alexander_mazur@rush.edu
- Phone: 312-942-5020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vasovagal Syncope, AV Block-2Nd Degree-Type 1, Sinus Pause, vasovagal syncope, av block, sinus pause, pacemaker, cardioneuroablation