Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation
NCT ID: NCT06058468
Last Updated: 2023-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
160 participants
INTERVENTIONAL
2024-01-31
2029-06-30
Brief Summary
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Detailed Description
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In CNA group the location of RAGP will be determined anatomically below the superior vena cava ostium near the superior-septal aspect of the right atrium. Radiofrequency (RF) applications will be delivered and will be continued until heart rate (HR) acceleration \>30% is achieved or if the RF time exceeds 120s.
In the PVI group point-by-point RF isolation of all pulmonary veins will be performed.
Clinical follow-up (FU) will consist of multiple ambulatory visits combined with standard ECG readings and a 7-day Holter recording. During FU visits, a detailed history of any palpitations, episodes of atrial fibrillation (AF), and hospitalizations for cardiac arrhythmias will be collected.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cardioneuroablation of right anterior ganglionated plexus
Cardioneuroablation of right anterior ganglionated plexus
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.
Pulmonary vein isolation
Pulmonary vein isolation
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.
Interventions
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Cardioneuroablation of right anterior ganglionated plexus
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.
Pulmonary vein isolation
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
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Inclusion Criteria
* Deceleration capacity \>7.5ms
* Life expectancy more than 1 year
* Age ≥18 years
Exclusion Criteria
* 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
* Contraindications to oral anticoagulation
* Contraindications to computed tomography or magnetic resonance imaging
* Pregnancy or breast-feeding
* BMI\>31
* 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
* Mental disorders
* Lack of informed consent to participate in the trial
18 Years
ALL
No
Sponsors
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St. Joseph's Centre, Poland
OTHER
Responsible Party
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Piotr Futyma
Professor
Central Contacts
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Other Identifiers
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2022/084/W
Identifier Type: -
Identifier Source: org_study_id
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