Consistency of LGE-MRI Fibrosis and EAM Low-voltage Area

August 13, 2024 updated by: China National Center for Cardiovascular Diseases

Exploratory Study of Consistency of Bi-Atrial Fibrosis Detected by Late Gadolinium Enhancement Magnetic Resonance Imaging and Low Voltage Area of Electroanatomic Mapping

This study aims to:

  1. Assess the consistency of LGE-MRI bi-atrial fibrosis and electroanatomical mapping of bi-atrial low voltage region
  2. To evaluate the electroanatomical characteristics of different types of fibrosis (dense fibrosis, patchy fibrosis, etc.) in different locations of the left and right atrium;
  3. To explore the correlation between preoperative and postoperative bi-atrial fibrosis and long-term recurrence in patients with atrial fibrillation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital, CAMS&PUMC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult AF patients who are planned to receive catheter ablation and have no contraindications of LGE-MRI

Description

Inclusion Criteria:

  1. Adult patients (≥18 years old) who are willing to participate in this study and can sign informed consent;
  2. Atrial fibrillation was diagnosed and catheter ablation was proposed

Exclusion Criteria:

  1. Left atrial thrombus or left atrial appendage thrombus;
  2. Severe chronic obstructive pulmonary disease (FEV1/ FVC<70%, FEV1<50% predicted value);
  3. Absolute contraindications of anticoagulation therapy;
  4. Currently pregnant;
  5. Contraindications for LGE-MRI (claustrophobia, pacemaker implantation, eGFR<30ml/min for renal insufficiency, severe obesity, pregnancy, gadolinium chelating agent allergy, etc.);
  6. refuse to participate in the study;
  7. other physical or mental incapacity to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational Group

Inclusion Criteria

  1. Adult patients (≥18 years old) who are willing to participate in this study and can sign informed consent;
  2. Atrial fibrillation was diagnosed and catheter ablation was proposed Exclusion criteria

a) Left atrial thrombus or left atrial appendage thrombus; b) Severe chronic obstructive pulmonary disease (FEV1/ FVC<70%, FEV1<50% predicted value); c) Absolute contraindications of anticoagulation therapy; d) Currently pregnant; e) Contraindications for LGE-MRI (claustrophobia, pacemaker implantation, eGFR<30ml/min for renal insufficiency, severe obesity, pregnancy, gadolinium chelating agent allergy, etc.); f) refuse to participate in the study; g) other physical or mental incapacity to participate in the study.
Diagnostic test: LGE-MRI Scan
Participants will receive LGE-MRI scan before catheter ablation and 3 months after catheter ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consistency of LGE-MRI fibrosis and EAM low-voltage area
Time Frame: Baseline (at recruit time point)
Use Registration to match the corresponding spatial points of LGE-MRI and EAM。Each spatial points will contain two types of status(Fibrosis: Yes/No, Low-voltage area: Yes/No). Chi-square test will be used to assess the consistency of fibrosis and low-voltage area.
Baseline (at recruit time point)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 11, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-2223

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD will be shared under the permission of primary investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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