Atrial Fibrillation ParoxysmalNCT05461859
Cardioneuroablation for the Treatment of Vagally-mediated Atrial Fibrillation.
An observational study of Atrial Fibrillation Paroxysmal, run by St. Joseph's Centre, Poland at 1 site in Poland.
Trial summary
Pulmonary vein isolation (PVI) is a cornerstone for catheter ablation of atrial fibrillation (AF), however, exact mechanisms of PVI efficacy remain debatable. It has been postulated that in patients with increased vagal tone AF can be treated by attenuation of parasympathetic drive to the heart using… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation Paroxysmal
- What is being tested?
- Cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP)
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 sitePoland
- Study dates
- 16 Mar 2020to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with paroxysmal AF who were scheduled for ablation of AF and in whom clinical parameters such as sinus bradycardia and AF paroxysms occurring during rest, night or after meals, suggested vagally-mediated AF, were considered for the study.
Who may be able to join
- Paroxysmal atrial fibrillation
- Deceleration capacity >7ms
Who cannot join
- Permanent AF lasting more than one year or persistent AF lasting more than 7 days
- AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-heart related causes
- Anteroposterior dimension of the left atrium in the echocardiography ≥ 5.5 cm
- Significant valvular disease
- Prosthetic valve
- Heart failure New York Heart Association (NYHA) class III/IV
Show all 25Show fewer
- Previous AF ablation
- History of a persistent oval opening/atrial septal defect closure
- History of left atrial appendage closure
- Atrial myxoma
- Presence of a cardiac pacemaker, defibrillator or cardiac resynchronization therapy device
- Symptomatic hypotension
- History of pericarditis
- Congenital heart disease
- History of coagulation disorders
- Contraindications to oral anticoagulation
- Contraindications to computed tomography or magnetic resonance imaging
- History of transplantation
- Severe lung disease
- Chronic renal failure defined as estimated glomerular filtration rate (eGFR) <30 mL/min/m2
- Cancer
- Significant infection
- Life expectancy less than one year
- Lack of informed consent to participate in the trial
- Participation in another trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Right Anterior Ganglionated Plexus Ablation Without Pulmonary Vein Isolation for the Treatment of Vagally-mediated Paroxysmal Atrial Fibrillation.
Pulmonary vein isolation (PVI) is a cornerstone for catheter ablation of atrial fibrillation (AF), however, exact mechanisms of PVI efficacy remain debatable. It has been postulated that in patients with increased vagal tone AF can be treated by attenuation of parasympathetic drive to the heart using cardioneuroablation (CNA) by means of radiofrequency (RF) of the ganglionated plexi, however, data in literature and guidelines are lacking. The objective of this study is to examine the mid-term efficacy of RF-CNA targeting the right anterior ganglionated plexus (RAGP) in management of AF using right-atrial approach only.
Read the detailed description
Calculation of deceleration capacity (DC) was derived from the result of 1-minute monitoring of R-R intervals recorded using electrophysiology (EP) system.
Double access to the right femoral vein was obtained under ultrasound guidance. Four- or ten-pole diagnostic electrode was introduced into the coronary sinus and an open-irrigated or 8 mm ablation catheter (AC) was advanced into the superior vena cava. The location of RAGP was determined purely anatomically at the sites of fragmented potentials below the superior vena cava ostium and the superior-septal aspect of the right atrium in the left anterior oblique (LAO) view and was guided fluoroscopically. RF applications were delivered and were continued until heart rate (HR) acceleration >30% was achieved or RF time exceeded 120 s.
Clinical follow-up (FU) consisted of multiple ambulatory visits with standard ECG and a 7-day Holter during the FU period. During FU visits, a detailed history of any palpitations, episodes of AF, and hospitalizations for cardiac arrhythmias was collected.
- Conditions
- Atrial Fibrillation Paroxysmal
- Being tested
- Cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP)
- Keywords
- Atrial Fibrillation, Vagally-mediated, Cardioneuroablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP)Procedure or surgery
CNA of RAGP
| Study group | Role | What they receive |
|---|---|---|
| ≥30% HR increase after CNA | Patients in whom ≥30% increase in HR after CNA of RAGP was achieved. Receives: Procedure: Cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP) | |
| <30% HR increase after CNA | Patients in whom ≥30% increase in HR after CNA of RAGP was *not* achieved. Receives: Procedure: Cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF recurrence
AF episode lasting 30s or more, documented on 12-lead ECG, event or Holter monitor
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start16 Mar 2020
- Primary completion19 Jul 2021
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation ParoxysmalStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Centre, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Futyma, St. Joseph's Centre, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461859
- Sponsor's protocol ID
- 42/2022/B
- Status last verified
- Nov 2023
- First submitted
- 12 Jul 2022
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Anterior Ganglionated Plexus Ablation Without Pulmonary Vein Isolation for the Treatment of Vagally-mediated Paroxysmal Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT05461859
- Acronym / sponsor ID
- 42/2022/B
- Conditions
- Atrial Fibrillation Paroxysmal
- Keywords
- Atrial Fibrillation, Vagally-mediated, Cardioneuroablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- St. Joseph's Centre, PolandUniversity, hospital or other
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 18 Jul 2022 (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.
Pulmonary vein isolation (PVI) is a cornerstone for catheter ablation of atrial fibrillation (AF), however, exact mechanisms of PVI efficacy remain debatable. It has been postulated that in patients with increased vagal tone AF can be treated by attenuation of parasympathetic drive to the heart using cardioneuroablation (CNA) by means of radiofrequency (RF) of the ganglionated plexi, however, data in literature and guidelines are lacking. The objective of this study is to examine the mid-term efficacy of RF-CNA targeting the right anterior ganglionated plexus (RAGP) in management of AF using right-atrial approach only.
Detailed description
Calculation of deceleration capacity (DC) was derived from the result of 1-minute monitoring of R-R intervals recorded using electrophysiology (EP) system.
Double access to the right femoral vein was obtained under ultrasound guidance. Four- or ten-pole diagnostic electrode was introduced into the coronary sinus and an open-irrigated or 8 mm ablation catheter (AC) was advanced into the superior vena cava. The location of RAGP was determined purely anatomically at the sites of fragmented potentials below the superior vena cava ostium and the superior-septal aspect of the right atrium in the left anterior oblique (LAO) view and was guided fluoroscopically. RF applications were delivered and were continued until heart rate (HR) acceleration >30% was achieved or RF time exceeded 120 s.
Clinical follow-up (FU) consisted of multiple ambulatory visits with standard ECG and a 7-day Holter during the FU period. During FU visits, a detailed history of any palpitations, episodes of AF, and hospitalizations for cardiac arrhythmias was collected.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ≥30% HR increase after CNA | – | Procedure: Cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP)Patients in whom ≥30% increase in HR after CNA of RAGP was achieved. |
| <30% HR increase after CNA | – | Procedure: Cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP)Patients in whom ≥30% increase in HR after CNA of RAGP was *not* achieved. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with paroxysmal AF who were scheduled for ablation of AF and in whom clinical parameters such as sinus bradycardia and AF paroxysms occurring during rest, night or after meals, suggested vagally-mediated AF, were considered for the study.
Key inclusion criteria (2 listed)
- Paroxysmal atrial fibrillation
- Deceleration capacity >7ms
Key exclusion criteria (25 listed)
- Permanent AF lasting more than one year or persistent AF lasting more than 7 days
- AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-heart related causes
- Anteroposterior dimension of the left atrium in the echocardiography ≥ 5.5 cm
- Significant valvular disease
- Prosthetic valve
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 |
|---|---|---|
| Cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP)CNA of RAGP | Procedure or surgery | <30% HR increase after CNA, ≥30% HR increase after CNA |
Primary outcome
AF recurrence
Time frame: 1 year
AF episode lasting 30s or more, documented on 12-lead ECG, event or Holter monitor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Atrial Fibrillation Paroxysmal, run by St. Joseph's Centre, Poland at 1 site in Poland.
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 25 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: finished, as of the sponsor's last update on 27 Nov 2023. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF recurrence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2023; AzTrials last refreshed its copy on 9 Nov 2026.