Status:
UNKNOWN
Pulsed-field Ablation for Patients With Asymptomatic Non-paroxysmal Atrial Fibrillation
Lead Sponsor:
Charles University, Czech Republic
Collaborating Sponsors:
Regional Hospital Liberec
Nemocnice AGEL Trinec-Podlesi a.s.
Conditions:
Atrial Fibrillation
Pulsed-field Ablation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
Background According to the current guidelines, catheter ablation (CA) for atrial fibrillation (AF) is recommended for rhythm control therapy in patients with paroxysmal or non-paroxysmal AF to improv...
Eligibility Criteria
Inclusion
- non-paroxysmal AF
- absence of symptoms during standard clinical evaluation
- AFEQT\> 80
- NT-pro BNP \< 800 pg/mL
Exclusion
- significant valvular disease
- left ventricular dysfunction - LV EF \< 50 %
- history of tachycardia - induced cardiomyopathy
- pulmonary hypertension (sPAP \> 40 mm Hg)
- age \> 75 years
- LA size \> 60 mm
- physical limitations that don't enable functional cardiopulmonary exercise testing
- overt coronary artery disease
- pregnancy
- BMI \> 40
- chronic obstructive pulmonary disease with moderate or severe obstruction
- life expectancy less than 2 years
- permanent AF
- ophthalmological medication (eye drops) containing beta-blockers
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT06166524
Start Date
January 1 2024
End Date
December 31 2025
Last Update
December 12 2023
Active Locations (1)
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1
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Prague, Czechia, 10034