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Status unknownNCT04524741Updated Apr 14, 2023

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

An interventional study of intracardiac echocardiography in Left Atrial Appendage Occlusion, sponsored by The Second Hospital of Hebei Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-04-14.

Sponsored by The Second Hospital of Hebei Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

A total of 40 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.

02

Conditions studied

  • Left Atrial Appendage Occlusion
03

In context

Lead sponsor

The Second Hospital of Hebei Medical University is the lead sponsor of 21 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    left atrial appendage radiography

    Device: intracardiac echocardiography

  • Experimental
    intracardiac echocardiography guidance

    Device: intracardiac echocardiography

Interventions

  • Deviceintracardiac echocardiography

    30 patients use intracardiac echocardiography to guide left atrial appendage occluder device, 30 patients use radiography to guide left atrial appendage occluder device.

    Also known as: left atrial appendage radiography

06

What researchers measure

Primary outcomes

  1. record contrast media as well as fluoroscopy time were recorded

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

    Time frame: in the procedure

  2. measure left atrial appendage opening and depth in different angles by intracardiac echocardiography

    use intracardiac echocardiography to measure left atrial appendage opening and

    Time frame: in the procedure

  3. measure left atrial appendage opening and depth in different angles by radiography

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

    Time frame: in the procedure

07

Study locations

1 of 1 sites recruiting
  • The Second Hospital of Hebei Medical University
    Shijiazhuang, Hebei 050000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04524741
Lead sponsor
The Second Hospital of Hebei Medical University
Responsible party
Sponsor
First posted
Aug 24, 2020
Start date
Jun 1, 2020
Primary completion
Dec 1, 2023 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
Apr 14, 2023

Study contacts

Xie Ruiqin
Contact
13230178060@163.com
13230178060

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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