Left Atrial Appendage VelocityNCT04693871
Effect of Left Atrial Appendage Velocity on Left Atrial Structure and Function After Radiofrequency Ablation Combined With Left Atrial Appendage Occlusion
An observational study of Left Atrial Appendage Velocity and Left Atrial Structure, run by The Second Hospital of Hebei Medical University at 1 site in China.
Trial summary
Radiofrequency ablation of atrial fibrillation combined with left atrial appendage closure can not only improve symptoms in patients with non-valvular atrial fibrillation, but also prevent left atrial appendage thrombosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Left Atrial Appendage Velocity, Left Atrial Structure, Left Atrial Function
- What is being tested?
- Transesophageal ultrasound
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Jan 2021
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-valvular atrial fibrillation between the ages of 18 and 80 received atrial fibrillation radiofrequency ablation combined with left atrial appendage occlusion, and recovered to sinus rhythm after the operation. According to the different left atrial appendage emptying speed, it is divided into a higher left atrial appendage emptying speed group and a lower left atrial appendage emptying speed group.
Who may be able to join
- Patients who received atrial fibrillation radiofrequency ablation combined with left atrial appendage closure.
- Exclude Criteria
- Patients with incomplete data.
- Device embolism.
- Residual shunt around the device found by transesophageal echocardiography greater than 5 mm.
- Mitral valve stenosis.
Show all 10Show fewer
- Artificial valve.
- Atrial septal defect.
- Dilated cardiomyopathy
- Moderate Severe mitral regurgitation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: Effect of Left Atrial Appendage Velocity on Left Atrial Structure and Function After Radiofrequency Ablation Combined With Left Atrial Appendage Occlusion.
Radiofrequency ablation of atrial fibrillation combined with left atrial appendage closure can not only improve symptoms in patients with non-valvular atrial fibrillation, but also prevent left atrial appendage thrombosis. The safety and effectiveness of left atrial appendage occlusion have been confirmed by randomized controlled trials and actual experience. Among patients with different left atrial appendage emptying speeds, there are limited studies on the structure and function of the left atrial appendage after LAA closure. In this study, patients with persistent nonvalvular atrial fibrillation were selected for radiofrequency ablation combined with LAA closure. The sinus rhythm was restored after the operation. According to the different emptying speed of the left atrial appendage, they were divided into a high-flow rate group and a low-flow rate group. The differences in the structure and function of the left atrium between the two groups were analyzed.
- Being tested
- Transesophageal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal ultrasoundDevice
Also called Radiofrequency ablation of atrial fibrillation combined with left atrial appendage closure
Patients with nonvalvular atrial fibrillation underwent radiofrequency ablation combined with left atrial appendage closure and recovered to sinus rhythm after the operation. To study the changes of left atrial organization and function of two groups of patients with different left atrial appendage emptying speeds.
| Study group | Role | What they receive |
|---|---|---|
| high-flow rate group | Not described Receives: Device: Transesophageal ultrasound | |
| low-flow rate group | Not described Receives: Device: Transesophageal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the structure of the left atrium
Measure the left atrial transverse diameter, anteroposterior diameter, upper and lower diameter.
Measured: 1year
Changes in the function of the left atrium
Left atrium volume. Two-chamber and four-chamber left atrium strain and strain rate, left atrium storage function, channel function and pump function.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Jan 2020
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Atrial Appendage VelocityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruiqin xie, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693871
- Sponsor's protocol ID
- XieRuiqinLAAEV
- Status last verified
- Jan 2020
- First submitted
- 10 Dec 2020
- Last updated
- 18 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Left Atrial Appendage Velocity on Left Atrial Structure and Function After Radiofrequency Ablation Combined With Left Atrial Appendage Occlusion.
- ClinicalTrials.gov ID
- NCT04693871
- Acronym / sponsor ID
- XieRuiqinLAAEV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Second Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 5 Jan 2021 (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.
Radiofrequency ablation of atrial fibrillation combined with left atrial appendage closure can not only improve symptoms in patients with non-valvular atrial fibrillation, but also prevent left atrial appendage thrombosis. The safety and effectiveness of left atrial appendage occlusion have been confirmed by randomized controlled trials and actual experience. Among patients with different left atrial appendage emptying speeds, there are limited studies on the structure and function of the left atrial appendage after LAA closure. In this study, patients with persistent nonvalvular atrial fibrillation were selected for radiofrequency ablation combined with LAA closure. The sinus rhythm was restored after the operation. According to the different emptying speed of the left atrial appendage, they were divided into a high-flow rate group and a low-flow rate group. The differences in the structure and function of the left atrium between the two groups were analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-flow rate group | – | Device: Transesophageal ultrasound |
| low-flow rate group | – | Device: Transesophageal ultrasound |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-valvular atrial fibrillation between the ages of 18 and 80 received atrial fibrillation radiofrequency ablation combined with left atrial appendage occlusion, and recovered to sinus rhythm after the operation. According to the different left atrial appendage emptying speed, it is divided into a higher left atrial appendage emptying speed group and a lower left atrial appendage emptying speed group.
Key inclusion criteria (10 listed)
- Patients who received atrial fibrillation radiofrequency ablation combined with left atrial appendage closure.
- Exclude Criteria
- Patients with incomplete data.
- Device embolism.
- Residual shunt around the device found by transesophageal echocardiography greater than 5 mm.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Transesophageal ultrasoundAlso: Radiofrequency ablation of atrial fibrillation combined with left atrial appendage closurePatients with nonvalvular atrial fibrillation underwent radiofrequency ablation combined with left atrial appendage closure and recovered to sinus rhythm after the operation. To study the changes of left atrial organization and function of two groups of patients with different left atrial appendage emptying speeds. | Device | high-flow rate group, low-flow rate group |
Primary outcome
Changes in the structure of the left atrium
Time frame: 1year
Measure the left atrial transverse diameter, anteroposterior diameter, upper and lower diameter.
Changes in the function of the left atrium
Time frame: 1year
Left atrium volume. Two-chamber and four-chamber left atrium strain and strain rate, left atrium storage function, channel function and pump function.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Atrial Appendage Velocity and Left Atrial Structure, 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 10 inclusion and 0 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: finished, as of the sponsor's last update on 18 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the structure of the left atrium (time frame: 1year). The study lists 2 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 18 Mar 2021.