Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation
Cardioneuroablation of Right Anterior Ganglionated Plexus vs Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation and Enhanced Vagal Tone
1 other identifier
interventional
160
0 countries
N/A
Brief Summary
The goal of this study is to compare effectiveness of cardioneuroablation of right anterior ganglionated plexus and pulmonary vein isolation in patients with enhanced vagal tone expressed as deceleration capacity \>7.5ms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
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
First Submitted
Initial submission to the registry
September 21, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
September 29, 2023
September 1, 2023
4 years
September 21, 2023
September 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AF recurrence
AF episode lasting 30 seconds or more, documented on 12-lead ECG, event or Holter monitoring
1 year
Study Arms (2)
Cardioneuroablation of right anterior ganglionated plexus
EXPERIMENTALPulmonary vein isolation
ACTIVE COMPARATORInterventions
Right anterior ganglionated plexus will be localized using anatomical approach. Radiofrequency energy will be delivered until heart rate acceleration \>30% is achieved or if radiofrequency time exceeds 120 seconds.
Application sites near the ostia of pulmonary veins will be determined. Radiofrequency energy will be delivered using point-by-point technique. After applications, the acute PVI endpoint will be confirmed by the elimination of PV potentials and lack of capture during pacing from the ablation lines.
Eligibility Criteria
You may qualify if:
- Paroxysmal atrial fibrillation documented in ECG or Holter monitoring
- Deceleration capacity \>7.5ms
- Life expectancy more than 1 year
- Age ≥18 years
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 ≥43mm
- Clinically significant arrhythmias other than AF
- Significant valvular disease
- Valve prosthesis
- Heart failure III or IV Class in New York Heart Association Classification
- Previous ablation of atrial fibrillation or atrial flutter
- History of a patent foramen ovale/atrial septal defect closure
- History of left atrial appendage closure
- Atrial myxoma
- Presence of a cardiac pacemaker, defibrillator or cardiac resynchronization therapy device
- History of pericarditis
- Congenital heart disease
- History of bleeding or coagulation disorders
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 21, 2023
First Posted
September 28, 2023
Study Start
January 1, 2024
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
June 1, 2029
Last Updated
September 29, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share