Rush University Medical Centert
Chicago, Illinois, 60657, United States
Location status: Recruiting
NCT Number: NCT06166277
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Observational
Chicago, Illinois, 60657, United States
Location status: Recruiting
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cardioneuroablation procedure or permanent pacemaker placement
Other names: Permanent pacemaker placement
Time frame: 3 years
Recurrent syncope
Time frame: 3 years
Time to first syncope episode since enrollment
Time frame: 3 years
Number of syncopal episodes
Time frame: 3 years
Number of pre syncopal episodes
Time frame: 1 year
Delta change in HR between pre-ablation and post-ablation
Time frame: 1 year
Major peri-procedural complications
Time frame: 1 year
QoL assessed by survey
Time frame: 3 years
Redo-ablation procedures for primary outcomes
Time frame: 3 years
Development of new atrial arrhythmias
Contact information is provided by the study sponsor or research team.
Alexander Mazur, MD
CONTACT
Jeanne du Fay de Lavallaz, MD
CONTACT
Rush University Medical Center
Other
Cardioneuroablation for the Management of Patients With Recurrent Vasovagal Syncope and Symptomatic Bradyarrhythmias: The CNA-FWRD Registry
Acronym: CNA-FWRD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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