Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation

Launched by ST. JOSEPH'S CENTRE, POLAND · Sep 27, 2023

Keywords

ClinConnect Summary

This clinical trial is designed to compare two different treatments for a heart condition called paroxysmal atrial fibrillation, which is an irregular heartbeat that comes and goes. Specifically, the study will look at the effectiveness of a procedure called cardioneuroablation, which targets specific nerve areas in the heart, versus a more common method known as pulmonary vein isolation, which blocks electrical signals in the heart. The trial is aimed at patients who have been found to have a certain level of nervous system influence on their heartbeat, indicated by a measure called deceleration capacity.

To participate in this study, individuals must be at least 18 years old and have documented episodes of paroxysmal atrial fibrillation. They should also have a deceleration capacity greater than 7.5 milliseconds and a life expectancy of more than one year. However, there are some conditions that would exclude someone from participating, such as having permanent or persistent atrial fibrillation, significant heart or lung diseases, or certain medical histories. Participants can expect to undergo the assigned treatment and will be monitored closely throughout the trial to assess how well the treatments work for their condition.

Gender

ALL

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