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NCT Number: NCT06552845

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Zhe Zheng, MD, PhD

CONTACT

[email protected]

+86 88396051

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

LGE-MRI Scan

Diagnostic Test

Participants will receive LGE-MRI scan before catheter ablation and 3 months after catheter ablation

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 14, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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