Inflammatory Response as a Prognostic Factor of Recurrence of Atrial Fibrillation After Ablation

Atrial Fibrillation Clinical Trial

— ACtIVE-AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02844959
• Other study ID #: KB/143/2016
• Status: Recruiting
• Phase: N/A
• First received: July 22, 2016
• Last updated: July 25, 2016
• Start date: July 2016
• Est. completion date: July 2018

Study information

• Verified date: July 2016
• Source: Medical University of Warsaw
• Contact: Michal Peller, MD
• Phone: 694 914 962
• Email: michalpeller[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Poland	1st Department of Cariology of Medcial University of Warsaw	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation within the first 7 days after ablation		within the first 7 days after ablation	No
Secondary	Atrial fibrillation within 6 months after ablation		6 months	No