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Biomarkers in Pulsed Field Ablation Versus Cryoballoon Ablation

Sponsor
Ana Jordan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05862038
Collaborator
(none)
100
Enrollment
1
Location
19
Anticipated Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Biomarkers in Pulsed Field Ablation Versus Cryoballoon Ablation
    Actual Study Start Date :
    Feb 10, 2023
    Anticipated Primary Completion Date :
    Jul 10, 2024
    Anticipated Study Completion Date :
    Sep 10, 2024

    Outcome Measures

    Primary Outcome Measures

    1. To see if PFA vs CBA increase left atrium stifness by measuring NT-proBNP values after procedures [One year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UH Dubrava Zagreb Croatia 10000

    Sponsors and Collaborators

    • Ana Jordan

    Investigators

    • Principal Investigator: Ana Jordan, University Hospital Dubrava

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ana Jordan, Principal investigator, University Hospital Dubrava
    ClinicalTrials.gov Identifier:
    NCT05862038
    Other Study ID Numbers:
    • KBD01
    First Posted:
    May 17, 2023
    Last Update Posted:
    May 19, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of May 19, 2023