Inflammatory Response as a Prognostic Factor of Recurrenc... | NCT02844959

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

NCT02844959

Sponsor

Medical University of Warsaw

Status

Unknown status

Last Update Posted

Jul 26, 2016Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Jul 2017Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

Jul 22, 2016

First Submission Date that Met QC Criteria

Jul 25, 2016

First Posted Date

Jul 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2016

Last Update Posted Date

Jul 26, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marcin Grabowski, Clinical Professor, Marcin Grabowski, Medical University of Warsaw, Medical University of WarsawPrincipal Investigator

Lead Sponsor

Medical University of WarsawOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Atrial fibrillation within the first 7 days after ablation		within the first 7 days after ablation

Secondary Outcomes

Measure	Description	Time Frame
Atrial fibrillation within 6 months after ablation		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michał Peller, MD	Contact	694 914 962	0048	michalpeller@gmail.com
Krzysztof Ozierański, MD	Contact	509 996 947	0048	krzysztof.ozieranski@gmail.com

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
1st Department of Cariology of Medcial University of Warsaw	Recruiting	Warsaw	Masovian Voivodeship	02-097	Poland

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Michał Peller, MDContact694 914 962(ext. 0048)michalpeller@gmail.com
Krzysztof Ozierański, MDContact509 996 947(ext. 0048)krzysztof.ozieranski@gmail.com
Michał Peller, MDPrincipal Investigator
Krzysztof Ozierański, MDSub-Investigator
Paweł Balsam, PhDSub-Investigator
Piotr Lodziński, PhDSub-Investigator
Marcin D Grabowski, PhDSub-Investigator
Grzegorz Opolski, ProfessorSub-Investigator
Kacper Maciejewski, studentSub-Investigator