Biomarkers in Pulsed Field Ablation Versus Cryoballoon Ablation

Ana Jordan

Status: Enrolling

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Other

Identifiers

NCT05862038

KBD01

Details and patient eligibility

About

Our study will include consecutive patients undergoing pulsed field ablation (PFA) or cryoballoon (CBA) ablation. Tissue injury and inflammation markers will be measured before and after the procedure.

Full description

Study population:

The participants with symptomatic atrial fibrillation scheduled for PFA or CBA procedures Biomarkers of interest: high-sensitive troponin, CRP, NT-proBNP Data collection: Blood samples will be collected at baseline, immediately after the procedure, 24 hours after, and three months after.

Statistical analysis:

Comparisons of biomarker levels between PFA and CBA groups.

Results:

Comparison of biomarker levels between PFA and CBA groups at each time point. Changes in biomarker levels over time within each group. Correlation analysis between biomarker levels and clinical outcomes, such as AF recurrence, LA stiffness, complications, and hospitalization.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic paroxysmal or persistent atrial fibrillation.
• Age between 18 and 75 years.

Exclusion criteria

• Prior atrial fibrillation ablation.
• History of significant bleeding or thromboembolic events within the last 6 months.
• History of severe renal or liver disease.
• History of malignancy within the last 5 years.
• History of autoimmune disease or immunodeficiency.
• Significant mitral stenosis or other significant valvular heart disease.
• Pregnancy or breastfeeding.