Vasovagal SyncopeCNA-FWRDNCT06166277
Cardioneuroablation for Recurrent Vasovagal Syncope and Bradyarrhythmias: The CNA-FWRD Registry
An observational study of Vasovagal Syncope and AV Block-2Nd Degree-Type 1, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vasovagal Syncope, AV Block-2Nd Degree-Type 1, Sinus Pause
- What is being tested?
- Ablation procedure
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 30 Apr 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: Patients with vasovagal syncope or symptomatic bradyarrhythmia
Who may be able to join
- symptomatic vasovagal syncope or symptomatic bradyarrhythmia refractory to behavioral and medical measures
- age < 60 years
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rush University Medical Centert
Chicago, Illinois, 60657
Henry D Huang, MD, 312-942-5020, henry_d_huang@rush.edu
About this study
Official title: Cardioneuroablation for the Management of Patients With Recurrent Vasovagal Syncope and Symptomatic Bradyarrhythmias: The CNA-FWRD Registry
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.
Read the 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.
- Conditions
- Vasovagal Syncope, AV Block-2Nd Degree-Type 1, Sinus Pause
- Being tested
- Ablation procedure
- Keywords
- vasovagal syncope, av block, sinus pause, pacemaker, cardioneuroablation, radiofrequency ablation
- Medical subject headings
- Syncope, Vasovagal, Atrial Standstill, Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation procedureProcedure or surgery
Also called Permanent pacemaker placement
Cardioneuroablation procedure or permanent pacemaker placement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Ablation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Syncope
Recurrent syncope
Measured: 3 years
Secondary outcomes (8)
Time to first syncopal recurrence
Time to first syncope episode since enrollment
Measured: 3 years
Syncope burden
Number of syncopal episodes
Measured: 3 years
Presyncope burden
Number of pre syncopal episodes
Measured: 3 years
Ablation induced change in heart rate
Delta change in HR between pre-ablation and post-ablation
Measured: 1 year
Complications associated with GP ablation
Major peri-procedural complications
Measured: 1 year
Quality of life before and 12 months after ablation
QoL assessed by survey
Measured: 1 year
Redo-ablation procedures
Redo-ablation procedures for primary outcomes
Measured: 3 years
Atrial arrhythmias
Development of new atrial arrhythmias
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vasovagal SyncopeStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tolga Aksu, MD, Study chair, Yepedite University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166277
- Sponsor's protocol ID
- CNA-FWRD
- Acronym
- CNA-FWRD
- Status last verified
- Sep 2025
- First submitted
- 4 Dec 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15670960Pachon 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.
PubMed 21712276Scanavacca 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.
PubMed 31314822Aksu 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.
PubMed 34465122Piotrowski 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.
PubMed 36114133
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardioneuroablation for the Management of Patients With Recurrent Vasovagal Syncope and Symptomatic Bradyarrhythmias: The CNA-FWRD Registry
- ClinicalTrials.gov ID
- NCT06166277
- Acronym / sponsor ID
- CNA-FWRD / CNA-FWRD
- Conditions
- Vasovagal Syncope, AV Block-2Nd Degree-Type 1, Sinus Pause
- Keywords
- vasovagal syncope, av block, sinus pause, pacemaker, cardioneuroablation, radiofrequency ablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Awaiting the intervention, medically managed patients will remain in the control group for analysis purposes |
| Procedural group | – | Procedure: Ablation procedureAfter undergoing successful radiofrequency cardioneuroablation or permanent pacemaker procedures the patient will cross-over to the procedural group for analysis purposes |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients with vasovagal syncope or symptomatic bradyarrhythmia
Key inclusion criteria (2 listed)
- symptomatic vasovagal syncope or symptomatic bradyarrhythmia refractory to behavioral and medical measures
- age < 60 years
Key exclusion criteria (11 listed)
- age > 60 years
- intra-/infra-Hisian AV block
- intrinsic sinus node disease
- history of supraventricular tachycardia
- history of ventricular tachycardia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation procedureAlso: Permanent pacemaker placementCardioneuroablation procedure or permanent pacemaker placement | Procedure or surgery | Procedural group |
Primary outcome
Syncope
Time frame: 3 years
Recurrent syncope
8 secondary outcomes
Time to first syncopal recurrence
Time frame: 3 years
Syncope burden
Time frame: 3 years
Presyncope burden
Time frame: 3 years
Ablation induced change in heart rate
Time frame: 1 year
Complications associated with GP ablation
Time frame: 1 year
Quality of life before and 12 months after ablation
Time frame: 1 year
Redo-ablation procedures
Time frame: 3 years
Atrial arrhythmias
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Results publication: PubMed 15670960Pachon 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.
- Results publication: PubMed 21712276Pachon 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.
- Results publication: PubMed 31314822Scanavacca 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.
- Results publication: PubMed 34465122Aksu 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.
- Results publication: PubMed 36114133Piotrowski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tolga Aksu, MD study chair
Yepedite University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasovagal Syncope and AV Block-2Nd Degree-Type 1, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Mazur, MD (312-942-5020, alexander_mazur@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Syncope (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06166277, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.