Cardioneuroablation for the Treatment of Vagally-mediated Atrial Fibrillation.
Right Anterior Ganglionated Plexus Ablation Without Pulmonary Vein Isolation for the Treatment of Vagally-mediated Paroxysmal Atrial Fibrillation.
1 other identifier
observational
18
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2021
CompletedFirst Submitted
Initial submission to the registry
July 12, 2022
CompletedFirst Posted
Study publicly available on registry
July 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedNovember 27, 2023
November 1, 2023
1.3 years
July 12, 2022
November 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AF recurrence
AF episode lasting 30s or more, documented on 12-lead ECG, event or Holter monitor
1 year
Study Arms (2)
≥30% HR increase after CNA
Patients in whom ≥30% increase in HR after CNA of RAGP was achieved.
<30% HR increase after CNA
Patients in whom ≥30% increase in HR after CNA of RAGP was \*not\* achieved.
Interventions
CNA of RAGP
Eligibility Criteria
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.
You may qualify if:
- Paroxysmal atrial fibrillation
- Deceleration capacity \>7ms
You may not qualify if:
- 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
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Joseph's Heart Rhythm Center
Rzeszów, 35623, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 12, 2022
First Posted
July 18, 2022
Study Start
March 16, 2020
Primary Completion
July 19, 2021
Study Completion
January 1, 2023
Last Updated
November 27, 2023
Record last verified: 2023-11