Inflammatory Response as a Prognostic Factor of Recurrence of Atrial Fibrillation After Ablation
ACtIVE-AF
Assessment of Course of Inflammatory Biomarkers Concentrations After Pulmonary Veins Isolation as a Prognostic Factor of Atrial Fibrillation Treatment Effectiveness (ACtIVE-AF Study)
1 other identifier
observational
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 22, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedJuly 26, 2016
July 1, 2016
1 year
July 22, 2016
July 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Atrial fibrillation within the first 7 days after ablation
within the first 7 days after ablation
Secondary Outcomes (1)
Atrial fibrillation within 6 months after ablation
6 months
Eligibility Criteria
Study includes adult patients qualified for ablation due to atrial fibrillation.
You may qualify if:
- signed consent;
- criteria for ablation of atrial fibrillation.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1st Department of Cariology of Medcial University of Warsaw
Warsaw, Masovian Voivodeship, 02-097, Poland
Biospecimen
From each patient 10 ml of venous blood will be collected twice - just before ablation and 24 hours afterwards - and centrifugated to obtain serum.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marcin D Grabowski, PhD
1st Department of Cardiology Medical University of Warsaw
- STUDY CHAIR
Paweł Balsam, 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor, Marcin Grabowski, Medical University of Warsaw
Study Record Dates
First Submitted
July 22, 2016
First Posted
July 26, 2016
Study Start
July 1, 2016
Primary Completion
July 1, 2017
Study Completion
July 1, 2018
Last Updated
July 26, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will share