Clinical trial NCT06058468: Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation
Official title: Cardioneuroablation of Right Anterior Ganglionated Plexus vs Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation and Enhanced Vagal Tone
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation Paroxysmal
Keywords: Atrial Fibrillation
Vagally-mediated
Cardioneuroablation
Lead sponsor: St. Joseph's Centre, Poland
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: Inclusion Criteria:

* Paroxysmal atrial fibrillation documented in ECG or Holter monitoring
* Deceleration capacity \>7.5ms
* Life expectancy more than 1 year
* Age ≥18 years

Exclusion Criteria:

* 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

Primary outcomes:
measure: AF recurrence
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: