Inflammatory Response as a Prognostic Factor of Recurrence of Atrial Fibrillation After Ablation (ACtIVE-AF)

July 25, 2016 updated by: Marcin Grabowski, Medical University of Warsaw

Assessment of Course of Inflammatory Biomarkers Concentrations After Pulmonary Veins Isolation as a Prognostic Factor of Atrial Fibrillation Treatment Effectiveness (ACtIVE-AF Study)

The aim of this study is to evaluate inflammatory response as a prognostic factor of atrial fibrillation recurrency after ablation. Inflammatory response will be assessed by double measurement of C-reactive protein, fibroblast growth factor 2 (FGF2), matrix metallopeptidase 8 (MMP8) and body temperature. Dynamics of change of troponin I will be measured additionally.

After ablation each patient will be monitored with ECG telemonitoring system for 7 days.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

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

Study Locations

  • Poland
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-097
        • Recruiting
        • 1st Department of Cariology of Medcial University of Warsaw
        • Sub-Investigator:
          • Grzegorz Opolski, Professor
        • Sub-Investigator:
          • Paweł Balsam, PhD
        • Sub-Investigator:
          • Marcin D Grabowski, PhD
        • Contact:
        • Sub-Investigator:
          • Piotr Lodziński, PhD
        • Sub-Investigator:
          • Krzysztof Ozierański, MD
        • Sub-Investigator:
          • Kacper Maciejewski, student
        • Contact:
        • Principal Investigator:
          • Michał Peller, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study includes adult patients qualified for ablation due to atrial fibrillation.

Description

Inclusion Criteria:

  • signed consent;
  • criteria for ablation of atrial fibrillation.

Exclusion Criteria:

  • previous pulmonary veins isolation;
  • ablation other than pulmonary veins isolation during the procedure;
  • atrial fibrillation at the beginning of ablation procedure;
  • usage of 'single shot' devices.

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
Atrial fibrillation within the first 7 days after ablation
Time Frame: within the first 7 days after ablation
within the first 7 days after ablation

Secondary Outcome Measures

Outcome Measure
Time Frame
Atrial fibrillation within 6 months after ablation
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Medical University of Warsaw

Investigators

  • Study Chair: Marcin D Grabowski, PhD, 1st Department of Cardiology Medical University of Warsaw
  • Study Chair: Piotr Lodziński, PhD, 1st Department of Cardiology Medical University of Warsaw
  • Study Chair: Grzegorz Opolski, Professor, 1st Department of Cardiology Medical University of Warsaw
  • Study Chair: Paweł Balsam, PhD, 1st Department of Cardiology Medical University of Warsaw

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

July 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

July 22, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB/143/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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