Biomarkers in Pulsed Field Ablation Versus Cryoballoon Ablation

NCT ID: NCT05862038

Last Updated: 2023-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-10

Study Completion Date

2024-09-10

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ana Jordan

OTHER

Sponsor Role lead

Responsible Party

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Ana Jordan

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ana Jordan

Role: PRINCIPAL_INVESTIGATOR

University Hospital Dubrava

Locations

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UH Dubrava

Zagreb, , Croatia

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Ana Jordan

Role: CONTACT

00385986113086

Other Identifiers

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KBD01

Identifier Type: -

Identifier Source: org_study_id

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