Left Atrial Appendage OcclusionNCT04524780
Use of Intracardiac Echocardiography or Left Atrial Appendage Radiography to Guide Implantation of a Left Atrial Appendage Occlusion Device.
A study testing intracardiac echocardiography in people with Left Atrial Appendage Occlusion, run by The Second Hospital of Hebei Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Left Atrial Appendage Occlusion
- What is being tested?
- intracardiac echocardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Xie Ruiqin, doctor
About this study
Official title: Use of Intracardiac Echocardiography or Left Atrial Appendage Radiography to Guide Implantation of a Left Atrial Appendage Occlusion Device
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.
- Conditions
- Left Atrial Appendage Occlusion
- Being tested
- intracardiac echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracardiac echocardiographyDevice
Also called left atrial appendage radiography
30 patients use intracardiac echocardiography to guide left atrial appendage occluder device, 30 patients use radiography to guide left atrial appendage occluder device.
| Study group | Role | What they receive |
|---|---|---|
| left atrial appendage radiography | Experimental | Not described Receives: Device: intracardiac echocardiography |
| intracardiac echocardiography guidance | Experimental | Not described Receives: Device: intracardiac echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
record contrast media as well as fluoroscopy time were recorded
record contrast media as well as fluoroscopy time were recorded in all patients
Measured: in the procedure
measure left atrial appendage opening and depth in different angles by intracardiac echocardiography
use intracardiac echocardiography to measure left atrial appendage opening and depth
Measured: in the procedure
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
Measured: in the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Jun 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Atrial Appendage OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524780
- Sponsor's protocol ID
- Xieruiqin/ICE
- Status last verified
- Aug 2021
- First submitted
- 20 Aug 2020
- Last updated
- 23 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Intracardiac Echocardiography or Left Atrial Appendage Radiography to Guide Implantation of a Left Atrial Appendage Occlusion Device
- ClinicalTrials.gov ID
- NCT04524780
- Acronym / sponsor ID
- Xieruiqin/ICE
- Conditions
- Left Atrial Appendage Occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Second Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| left atrial appendage radiography | Experimental | Device: intracardiac echocardiography |
| intracardiac echocardiography guidance | Experimental | Device: intracardiac echocardiography |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intracardiac echocardiographyAlso: left atrial appendage radiography30 patients use intracardiac echocardiography to guide left atrial appendage occluder device, 30 patients use radiography to guide left atrial appendage occluder device. | Device | intracardiac echocardiography guidance, left atrial appendage radiography |
Primary outcome
record contrast media as well as fluoroscopy time were recorded
Time frame: in the procedure
record contrast media as well as fluoroscopy time were recorded in all patients
measure left atrial appendage opening and depth in different angles by intracardiac echocardiography
Time frame: in the procedure
use intracardiac echocardiography to measure left atrial appendage opening and depth
measure left atrial appendage opening and depth in different angles by radiography
Time frame: in the procedure
use left atrial appendage radiography to measure left atrial appendage opening and depth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intracardiac echocardiography in people with Left Atrial Appendage Occlusion, run by The Second Hospital of Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xie Ruiqin (13230178060, 13230178060@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
record contrast media as well as fluoroscopy time were recorded (time frame: in the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.