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Use of Intracardiac Echocardiography or Left Atrial Appendage Radiography to Guide Implantation of a Left Atrial Appendage Occlusion Device.

Sponsor
The Second Hospital of Hebei Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04524780
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
18
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A total of 60 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and left atrial appendage radiography, respectively (allocation ratio 1:1). During the operation, the total amount of contrast medium injected, the fluoroscopy time and the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients. The diameter and depth of the left atrial appendage opening were measured by angiography in group A(ICE group), and measured by ICE in group B(radiography group). The size of the occluder device was selected according to the measurement size of the two groups, the occluder device success rate of the two groups was compared, and the relationship between measurement size and the size of the occluder device was obtained.

Condition or Disease Intervention/Treatment Phase
  • Device: intracardiac echocardiography
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A total of 60 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and left atrial appendage radiography, respectively (allocation ratio 1:1).A total of 60 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and left atrial appendage radiography, respectively (allocation ratio 1:1).
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Use of Intracardiac Echocardiography or Left Atrial Appendage Radiography to Guide Implantation of a Left Atrial Appendage Occlusion Device
Actual Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: left atrial appendage radiography

Device: intracardiac echocardiography
30 patients use intracardiac echocardiography to guide left atrial appendage occluder device, 30 patients use radiography to guide left atrial appendage occluder device.
Other Names:
  • left atrial appendage radiography

    		•
    Experimental: intracardiac echocardiography guidance

    Device: intracardiac echocardiography
    30 patients use intracardiac echocardiography to guide left atrial appendage occluder device, 30 patients use radiography to guide left atrial appendage occluder device.
    Other Names:
  • left atrial appendage radiography

    		•

    Outcome Measures

    Primary Outcome Measures

    1. record contrast media as well as fluoroscopy time were recorded [in the procedure]

      record contrast media as well as fluoroscopy time were recorded in all patients

    2. measure left atrial appendage opening and depth in different angles by intracardiac echocardiography [in the procedure]

      use intracardiac echocardiography to measure left atrial appendage opening and depth

    3. measure left atrial appendage opening and depth in different angles by radiography [in the procedure]

      use left atrial appendage radiography to measure left atrial appendage opening and depth

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    patients taking class I and class III antiarrhythmic drugs could not prevent atrial fibrillation, patients younger than 80 years old Cha2ds2-vasc score ≥2 and Has-bled score ≥3, not suitable for long-term oral anticoagulant drugs.

    Exclusion Criteria:

    Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation), patients undergoing prosthetic heart valve replacement, pregnant women, patients with previous liver and kidney diseases, malignant tumors or blood system diseases.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Second Hospital of Hebei Medical University Shijiazhuang Hebei China

    Sponsors and Collaborators

    • The Second Hospital of Hebei Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Second Hospital of Hebei Medical University
    ClinicalTrials.gov Identifier:
    NCT04524780
    Other Study ID Numbers:
    • Xieruiqin/ICE
    First Posted:
    Aug 24, 2020
    Last Update Posted:
    Sep 23, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 23, 2021