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NCT05862038 Clinical Trial

Biomarkers in Pulsed Field Ablation Versus Cryoballoon Ablation

Atrial Fibrillation Clinical Trial

Official title:
Biomarkers in Pulsed Field Ablation Versus Cryoballoon Ablation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05862038
Other study ID # KBD01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 10, 2023
Est. completion date September 10, 2024

Study information
Verified date May 2023
Source University Hospital Dubrava
Contact Ana Jordan
Phone 00385986113086
Email anazovko4@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date September 10, 2024
Est. primary completion date July 10, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Croatia UH Dubrava Zagreb

Sponsors (1)
Lead Sponsor Collaborator
Ana Jordan

Country where clinical trial is conducted

Croatia, 

Outcome
Type Measure Description Time frame Safety issue
Primary To see if PFA vs CBA increase left atrium stifness by measuring NT-proBNP values after procedures One year
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