Biomarkers in Pulsed Field Ablation Versus Cryoballoon Ablation

Recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT05862038
• Lead Sponsor: Ana Jordan

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-02-10
• Status Verified: 2023-05
• Study First Submitted: 2023-05-07
• Study First Submitted QC: 2023-05-07
• Study First Posted: 2023-05-17
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-19
• Primary Completion: 2024-07-10
• Study Completion: 2024-09-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To see if PFA vs CBA increase left atrium stifness by measuring NT-proBNP values after procedures	One year

Trial Locations

Locations (1)

UH Dubrava; 🇭🇷 Zagreb, Croatia