Pulsed-field Ablation for Patients With Asymptomatic Non-paroxysmal Atrial Fibrillation

Summary

The goal of the study is to test the hypothesis whether the treatment of patients with asymptomatic non-paroxysmal AF based on catheter ablation will be superior than conservative approach consisting of electrical cardioversion with AADs treatment in terms of significant improvement of functional exercise capacity. Secondary hypothesis is that mild functional improvement would be present also by achieving optimum heart rate by means of the titration of beta-blocker dose.

Patients with non-paroxysmal asymptomatic AF will be enrolled and randomized to either early invasive strategy arm (EIS;, i.e. catheter ablation), or conservative arm (CS; ie. cardioversion followed by antiarrhythmic drug treatment. As baseline examinations, functional cardiopulmonary exercise testing (CPET), Holter, recording, and echocardiography will be done. After one month, the procedure (catheter ablation or cardioversion) will be performed. Outpatients visits are scheduled at 3, 6, 9 and 12 months after the randomization. At each visit, ECG Holter recording will be done. CPET will be repeated at M3 and M12 visits. In patients in the CS arm with AF recurrence, the dose of BB will be optimized using smart watches (the goal \< 110/min on average, but to achieve 75% of predicted maximum heart rate). The endpoint will be the change in VO2 max between baseline and 12M CPET. Secondary endpoints will be AF burden, AF freedom, the change in the concentration of NT-proBNP, the change in the left atrial diameter and left ventricular ejection fraction, the proportion of patients with no improvement while in SR, and the improvement in the quality-of-life at 12 months.

Conditions

• Atrial Fibrillation
• Pulsed-field Ablation
• Functional Exercise Testing

Interventions

PROCEDURE

Catheter ablation for atrial fibrillation using pulsed-field energy

Patients will undergo pulmonary vein isolation using pulsed-field energy

PROCEDURE

Conservative arm

Patients will undergo electrical cardioversion with consequent treatment with antiarrhythmic drugs

Sponsors & Collaborators

• Regional Hospital Liberec

  collaborator OTHER

• Nemocnice AGEL Trinec-Podlesi a.s.

  collaborator OTHER

• Brno University Hospital

  collaborator OTHER

• University Hospital Ostrava

  collaborator OTHER

• VFN

  collaborator UNKNOWN

• Charles University, Czech Republic

  lead OTHER

Principal Investigators

• Pavel Osmančík · Cardiac center University Hospital Kralovske Vinohrady

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2025-12-01

Completion

2025-12-31

Countries

• Czechia

Study Locations