NCT02208102

Brief Summary

The purpose of this study is to assess if pre-ablation levels of inflammatory biomarkers serve as independent predictors of procedure outcome To evaluate the inflammatory activation following catheter ablation by measuring serum-biomarker levels 24-hours after the procedure and examine the predictive role in procedure success To study the association of certain biomarkers with specific types of AF (paroxysmal or persistent or long standing persistent)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

9 months

First QC Date

July 31, 2014

Last Update Submit

October 17, 2017

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, catheter ablation, blood-biomarkers

Outcome Measures

Primary Outcomes (1)

  • Arrhythmia recurrence

    Patients will be monitored for arrhythmia recurrence for 1 year after the ablation procedure. At the end of the study, biomarker data will be analyzed to see any predictive association with AFib recurrence

    1 year

Secondary Outcomes (1)

  • Left atrial scar

    During ablation procedure

Interventions

Radio-frequency catheter ablationPROCEDURE
Also known as: RFCA

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing catheter ablation for atrial fibrillation

You may qualify if:

  • Age: 50-70 years
  • Patients undergoing catheter ablation of atrial fibrillation
  • Able and willing to give written consent

You may not qualify if:

  • Reversible causes of AF such as pericarditis and hyperthyroidism
  • Associated chronic inflammatory diseases such as chronic gingivitis or peri-odontitis, rheumatoid Arthritis, IBD including Ulcerative Colitis and Crohn's disease, Lupus, Ankylosing Spondylitis, COPD, psoriasis, vasculitis
  • Any other co-morbid conditions except Diabetes and hypertension
  • Patients taking long-term anti-inflammatory, steroid medication, or immune suppression medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Cardiac Arrhythmia Institute, St. david's Medical Center

Austin, Texas, 78727, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma from whole blood

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2014

First Posted

August 4, 2014

Study Start

July 1, 2014

Primary Completion

April 1, 2015

Study Completion

May 1, 2016

Last Updated

October 19, 2017

Record last verified: 2017-10

Locations

US(1)