Status:
NOT_YET_RECRUITING
Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation
Lead Sponsor:
St. Joseph's Centre, Poland
Conditions:
Atrial Fibrillation Paroxysmal
Eligibility:
All Genders
18+ years
Phase:
NA
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 decelerat...
Detailed Description
Patients included into the study will be randomized to a group undergoing cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP) or pulmonary vein isolation (PVI). In CNA group th...
Eligibility Criteria
Inclusion
- Paroxysmal atrial fibrillation documented in ECG or Holter monitoring
- Deceleration capacity \>7.5ms
- Life expectancy more than 1 year
- Age ≥18 years
Exclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06058468
Start Date
January 1 2024
End Date
June 1 2029
Last Update
September 29 2023
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