Cardioneuroablation for Recurrent Vasovagal Syncope and Bradyarrhythmias: The CNA-FWRD Registry
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 60 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Case-Crossover
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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 |
|
Recruiting Locations
Chicago, Illinois 60657
More Details
- NCT ID
- NCT06166277
- Status
- Recruiting
- Sponsor
- Rush University Medical Center
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.