NCT05099783

Brief Summary

The investigators will conduct an observational trial, with outcome ascertainment at 3 months and 6 months after cardioversion. The primary objective is to demonstrate how cardioversion may aid in the regression of left atrial fibrosis in patients with persist atrial fibrillation as assessed by late gadolinium enhanced magnetic resonance imaging. The secondary objective is to assess the relationship between structural and functional changes with heart rhythm and heart rate.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

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

September 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

12 months

First QC Date

October 18, 2021

Last Update Submit

July 26, 2022

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillationlate gadolinium enhanced magnetic resonance imagingatrial fibrosis

Outcome Measures

Primary Outcomes (1)

  • The regression of left atrial fibrosis in patients with persist atrial fibrillation after cardioversion

    The change in left atrial fibrosis (the core and border zone area, percentage of left atrium and segments involved) using MRI imaging, from baseline to the second measurement.

    3 to 6 months

Secondary Outcomes (2)

  • The effects of sinus rhythm in global parameters of myocardial remodeling

    3 to 6 months

  • The effects of sinus rhythm in global parameters of myocardial remodeling

    3 to 6 months

Other Outcomes (1)

  • The predictive value of MRI for the maintenance of sinus rhythm

    0 months

Interventions

late gadolinium enhanced magnetic resonance imagingDIAGNOSTIC_TEST

Candidate inpatients or outpatients will be identified if pharmacological or electrical cardioversion has be performed and MRI were performed after cardioversion at least twice.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Candidate inpatients or outpatients will be identified if pharmacological or electrical cardioversion has be performed and LGE-MRI were performed after cardioversion at least twice.

You may qualify if:

  • Patients carry a diagnosis of Persistent Atrial Fibrillation
  • Patients have given informed consent
  • Pharmacological or electrical cardioversion has be performed successfully
  • late gadolinium enhanced magnetic resonance imaging (LGE-MRI) were performed after cardioversion at least twice

You may not qualify if:

  • Prior radiofrequency ablation treatment for atrial fibrillation
  • Prior cardiac surgical procedures
  • Individuals with cognitive impairments who are unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

Related Publications (3)

  • Thijssen VL, Ausma J, Liu GS, Allessie MA, van Eys GJ, Borgers M. Structural changes of atrial myocardium during chronic atrial fibrillation. Cardiovasc Pathol. 2000 Jan-Feb;9(1):17-28. doi: 10.1016/s1054-8807(99)00038-1.

    PMID: 10739903BACKGROUND

  • Hobbs WJ, Fynn S, Todd DM, Wolfson P, Galloway M, Garratt CJ. Reversal of atrial electrical remodeling after cardioversion of persistent atrial fibrillation in humans. Circulation. 2000 Mar 14;101(10):1145-51. doi: 10.1161/01.cir.101.10.1145.

    PMID: 10715261BACKGROUND

  • Marrouche NF, Wilber D, Hindricks G, Jais P, Akoum N, Marchlinski F, Kholmovski E, Burgon N, Hu N, Mont L, Deneke T, Duytschaever M, Neumann T, Mansour M, Mahnkopf C, Herweg B, Daoud E, Wissner E, Bansmann P, Brachmann J. Association of atrial tissue fibrosis identified by delayed enhancement MRI and atrial fibrillation catheter ablation: the DECAAF study. JAMA. 2014 Feb 5;311(5):498-506. doi: 10.1001/jama.2014.3.

    PMID: 24496537BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yuehui Yin

    The Second Affiliated Hospital of Chongqing Medical University

    STUDY DIRECTOR

Central Study Contacts

Yuehui Yin

CONTACT

+8613508335502yinyh63@163.com

Fang Qin

CONTACT

+8617308351199qinfangheart@126.com

Study Design

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

Study Record Dates

First Submitted

October 18, 2021

First Posted

October 29, 2021

Study Start

September 1, 2021

Primary Completion

August 30, 2022

Study Completion

August 31, 2022

Last Updated

July 28, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)