Biomarkers in Pulsed Field Ablation Versus Cryoballoon Ablation

May 17, 2023 updated by: Ana Jordan
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • UH Dubrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population includes patients who are diagnosed with symptomatic paroxysmal or persistent atrial fibrillation and who are scheduled to undergo catheter ablation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To see if PFA vs CBA increase left atrium stifness by measuring NT-proBNP values after procedures
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ana Jordan

Investigators

  • Principal Investigator: Ana Jordan, University Hospital Dubrava

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2023

Primary Completion (Anticipated)

July 10, 2024

Study Completion (Anticipated)

September 10, 2024

Study Registration Dates

First Submitted

May 7, 2023

First Submitted That Met QC Criteria

May 7, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBD01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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