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NCT Number: NCT06058468

Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardioneuroablation of right anterior ganglionated plexus

Procedure

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

Procedure

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.

Primary outcomes

  1. AF recurrence

    Time frame: 1 year

    AF episode lasting 30 seconds or more, documented on 12-lead ECG, event or Holter monitoring

Study contacts

Contact information is provided by the study sponsor or research team.

Piotr Futyma

CONTACT

[email protected]

+48 533 503 044

Sponsors and collaborators

Lead sponsor

St. Joseph's Centre, Poland

Other

Registry information

Official study title

Cardioneuroablation of Right Anterior Ganglionated Plexus vs Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation and Enhanced Vagal Tone

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Sep 28, 2023
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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