Vasovagal Syncope, AV Block-2Nd Degree-Type 1, Sinus Pause
Conditions
Keywords
vasovagal syncope, av block, sinus pause, pacemaker, cardioneuroablation, radiofrequency ablation
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.
Interventions
PROCEDUREAblation procedure
Cardioneuroablation procedure or permanent pacemaker placement
Sponsors
Rush University Medical Center
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Syncope | 3 years | Recurrent syncope |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Syncope burden | 3 years | Number of syncopal episodes |
| Presyncope burden | 3 years | Number of pre syncopal episodes |
| Ablation induced change in heart rate | 1 year | Delta change in HR between pre-ablation and post-ablation |
| Time to first syncopal recurrence | 3 years | Time to first syncope episode since enrollment |
| Quality of life before and 12 months after ablation | 1 year | QoL assessed by survey |
| Redo-ablation procedures | 3 years | Redo-ablation procedures for primary outcomes |
| Atrial arrhythmias | 3 years | Development of new atrial arrhythmias |
| Complications associated with GP ablation | 1 year | Major peri-procedural complications |
Countries
United States
Contacts
Primary ContactAlexander Mazur, MD
Backup ContactJeanne du Fay de Lavallaz, MD
Outcome results
None listed