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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation procedure | Procedure | Cardioneuroablation procedure or permanent pacemaker placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Syncope | Recurrent syncope | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first syncopal recurrence | Time to first syncope episode since enrollment | 3 years |
| Syncope burden | Number of syncopal episodes |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with vasovagal syncope or symptomatic bradyarrhythmia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Mazur, MD | Contact | 312-942-5020 | alexander_mazur@rush.edu | |
| Jeanne du Fay de Lavallaz, MD | Contact | 312-942-5000 | jeanne.dufaydelavallaz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tolga Aksu, MD | Yepedite University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Centert | Recruiting | Chicago | Illinois | 60657 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15670960 | Result | Pachon JC, Pachon EI, Pachon JC, Lobo TJ, Pachon MZ, Vargas RN, Jatene AD. "Cardioneuroablation"--new treatment for neurocardiogenic syncope, functional AV block and sinus dysfunction using catheter RF-ablation. Europace. 2005 Jan;7(1):1-13. doi: 10.1016/j.eupc.2004.10.003. | |
| 21712276 | Result | Pachon JC, Pachon EI, Cunha Pachon MZ, Lobo TJ, Pachon JC, Santillana TG. Catheter ablation of severe neurally meditated reflex (neurocardiogenic or vasovagal) syncope: cardioneuroablation long-term results. Europace. 2011 Sep;13(9):1231-42. doi: 10.1093/europace/eur163. Epub 2011 Jun 28. |
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| ID | Term |
|---|---|
| D019462 | Syncope, Vasovagal |
| C563984 | Atrial Standstill |
| D054537 | Atrioventricular Block |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 3 years |
| Presyncope burden | Number of pre syncopal episodes | 3 years |
| Ablation induced change in heart rate | Delta change in HR between pre-ablation and post-ablation | 1 year |
| Complications associated with GP ablation | Major peri-procedural complications | 1 year |
| Quality of life before and 12 months after ablation | QoL assessed by survey | 1 year |
| Redo-ablation procedures | Redo-ablation procedures for primary outcomes | 3 years |
| Atrial arrhythmias | Development of new atrial arrhythmias | 3 years |
| 31314822 | Result | Scanavacca M, Hachul D. Ganglionated Plexi Ablation to Treat Patients with Refractory Neurally Mediated Syncope and Severe Vagal-Induced Bradycardia. Arq Bras Cardiol. 2019 Jul 15;112(6):709-712. doi: 10.5935/abc.20190107. No abstract available. |
| 34465122 | Result | Aksu T, Gopinathannair R, Bozyel S, Yalin K, Gupta D. Cardioneuroablation for Treatment of Atrioventricular Block. Circ Arrhythm Electrophysiol. 2021 Sep;14(9):e010018. doi: 10.1161/CIRCEP.121.010018. Epub 2021 Sep 1. |
| 36114133 | Result | Piotrowski R, Baran J, Sikorska A, Krynski T, Kulakowski P. Cardioneuroablation for Reflex Syncope: Efficacy and Effects on Autonomic Cardiac Regulation-A Prospective Randomized Trial. JACC Clin Electrophysiol. 2023 Jan;9(1):85-95. doi: 10.1016/j.jacep.2022.08.011. Epub 2022 Aug 28. |
| D013575 | Syncope |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |