Atrial FibrillationACtIVE-AFNCT02844959
Inflammatory Response as a Prognostic Factor of Recurrence of Atrial Fibrillation After Ablation
An observational study of Atrial Fibrillation, run by Medical University of Warsaw at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2016to Jul 2018
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study includes adult patients qualified for ablation due to atrial fibrillation.
Who may be able to join
- signed consent;
- criteria for ablation of atrial fibrillation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
1st Department of Cariology of Medcial University of Warsaw
Warsaw, Masovian Voivodeship, 02-097
Michał Peller, MD, 694 914 962 ext. 0048, michalpeller@gmail.com
Krzysztof Ozierański, MD, 509 996 947 ext. 0048, krzysztof.ozieranski@gmail.com
About this study
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)
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.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Biomarkers, Inflammatory Response, C-reactive protein, FGF2, MMP8, troponin I, body temperature
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation within the first 7 days after ablation
Measured: within the first 7 days after ablation
Secondary outcomes (1)
Atrial fibrillation within 6 months after ablation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcin Grabowski, Medical University of Warsaw
- Investigators
- Marcin D Grabowski, PhD, Study chair, 1st Department of Cardiology Medical University of WarsawPaweł Balsam, PhD, Study chair, 1st Department of Cardiology Medical University of WarsawPiotr Lodziński, PhD, Study chair, 1st Department of Cardiology Medical University of WarsawGrzegorz Opolski, Professor, Study chair, 1st Department of Cardiology Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844959
- Sponsor's protocol ID
- KB/143/2016
- Acronym
- ACtIVE-AF
- Status last verified
- Jul 2016
- First submitted
- 22 Jul 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02844959
- Acronym / sponsor ID
- ACtIVE-AF / KB/143/2016
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Biomarkers, Inflammatory Response, C-reactive protein, FGF2, MMP8, troponin I, body temperature
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study includes adult patients qualified for ablation due to atrial fibrillation.
Key inclusion criteria (2 listed)
- signed consent;
- criteria for ablation of atrial fibrillation.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Atrial fibrillation within the first 7 days after ablation
Time frame: within the first 7 days after ablation
1 secondary outcome
Atrial fibrillation within 6 months after ablation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Individual participant dataSharing planned: Yes
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcin D Grabowski, PhD study chair
1st Department of Cardiology Medical University of Warsaw
Paweł Balsam, PhD study chair
1st Department of Cardiology Medical University of Warsaw
Piotr Lodziński, PhD study chair
1st Department of Cardiology Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michał Peller, MD (694 914 962 ext. 0048, michalpeller@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation within the first 7 days after ablation (time frame: within the first 7 days after ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.