Cardioneuroablation for Recurrent Vasovagal Syncope and Bradyarrhythmias: The CNA-FWRD Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorRush University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
symptomatic vasovagal syncope or symptomatic bradyarrhythmia refractory to behavioral and medical measures
age < 60 years
Disqualifiers
age > 60 years
intra-/infra-Hisian AV block
intrinsic sinus node disease
history of supraventricular tachycardia
Trial population
Patients with vasovagal syncope or symptomatic bradyarrhythmia
Trial design
Design model
Case-crossover
Time perspective
Prospective
Treatments tested in this trial
Ablation procedure
Procedure/SurgeryCardioneuroablation procedure or permanent pacemaker placement
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Control group0 interventions
Group B: Procedural group1 intervention
Trial outcomes
Primary outcomes
1
Syncope
Recurrent syncope
Time frame
3 yearsSecondary outcomes
1
Time to first syncopal recurrence
Time to first syncope episode since enrollment
Time frame
3 years2
Syncope burden
Number of syncopal episodes
Time frame
3 years3
Presyncope burden
Number of pre syncopal episodes
Time frame
3 years4
Ablation induced change in heart rate
Delta change in HR between pre-ablation and post-ablation
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov