NCT02958839

Brief Summary

To investigate whether fibroblast growth factor 23 can be used to predict recurrence after catheter ablation for atrial fibrillation and to provide an objective basis for the clinical selection of the optimal patients for catheter ablation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

November 4, 2016

Last Update Submit

November 4, 2016

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationFibroblast Growth factor 23

Outcome Measures

Primary Outcomes (1)

  • Incidence of the recurrence of atrial fibrillation

    The recurrence of atrial fibrillation is considered to be any episode of AF/AFL/AT after a blank period of 3 months after the procedure of catheter ablation

    after 3 months from the procedure of catheter ablation

Secondary Outcomes (3)

  • Plasma fibroblast growth factor 23 levels

    after 3 months from the procedure of catheter ablation

  • CHA2DS2-VASc score

    after 3 months from the procedure of catheter ablation

  • Cardiac CT evaluation

    after 3 months from the procedure of catheter ablation

Study Arms (2)

Recurrence Group

In the case control trial, patients who have any episode of atrial fibrillation/atrial flutter/atrial tachycardia after a blanking period of 3 months from the catheter ablation procedure will be assign to the recurrence group

Procedure: Catheter ablation

Non-recurrence Group

In the case control trial, patients who do not have any episode of atrial fibrillation/atrial flutter/atrial tachycardia after a blanking period of 3 months from the catheter ablation procedure will be assign to the recurrence group

Procedure: Catheter ablation

Interventions

Catheter ablationPROCEDURE

Patients with persistent or paroxysmal atrial fibrillation will go through catheter ablation

Non-recurrence GroupRecurrence Group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This research is going to recruit 200 consecutive patients with a history of atrial fibrillation for 180-360 days who intend to undergo catheter ablation. Atrial fibrillation is diagnosed according to guidelines; Patients with structural heart disease; renal or hepatic impairment; neoplastic disorders; atrial fibrillation precipitated by other diseases such as thyrotoxicosis; or diabetes will be excluded.

You may qualify if:

  • Have a history of atrial fibrillation for 180 to 360 days
  • Provide written informed consent, having understood the benefits and risks of participation in the trial

You may not qualify if:

  • Significant structural heart disease (including symptomatic coronary heart disease; prosthetic mitral or tricuspid valve; congenital heart disease where abnormality or its correction prohibits or increases the risk of ablation)
  • Atrial Fibrillation precipitated by other diseases (such as thyrotoxicosis)
  • Severe dysfunction of liver or kidney
  • Diabetes
  • Malignant tumor
  • Inability or refusal to provide written informed consent for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100019, China

Location

Related Publications (1)

  • Meng L, Yang Y, Zhang Z, Li G, Liu T. Predictive value of circulating fibroblast growth factor-23 on atrial fibrillation: A meta-analysis. Int J Cardiol. 2016 May 1;210:68-71. doi: 10.1016/j.ijcard.2016.02.100. Epub 2016 Feb 18. No abstract available.

    PMID: 26942328BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be obtained by a peripheral venipuncture and will be centrifuged at 3,200 \*g for 10 minutes at approximately 4℃ within an hour of collection. The serum will be separated into aliquots and stored at -80℃ until personnel blinded to the patients' clinical information performed the analysis.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Lei Li, MD

    Peking University Third Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
intern of cardiology

Study Record Dates

First Submitted

November 4, 2016

First Posted

November 8, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations

CN(1)