Atrial FibrillationLAAO-SHNCT03987945
Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation From Shanghai
An observational study of Atrial Fibrillation and Left Atrial Appendage Occlusion, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The prognostic implication of left atrial appendage occlusion (LAAO) procedure in non-valvular atrial fibrillation (NVAF) patients from China is still unclear. We aim to investigate the impact of LAAO procedure on subsequent clinical outcomes in patients from China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Left Atrial Appendage Occlusion
- What is being tested?
- left atrial appendage occlusion devices
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 30 Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with NVAF who are referred for LAAO procedure.
Who may be able to join
- Patients who were admitted for NVAF undergoing LAAO procedure between January 2014 and December 2017 in the Cardiology Department of Shanghai Tenth People's Hospital;
- Adult patients (>18 years old).
Who cannot join
- Patients with rheumatic valvular disease;
- Patients with sick sinus syndrome;
- Patients who had a history of cardiac surgery (i.e., CABG);
- patients who had received the catheter radiofrequency ablation procedure.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Mengmeng Gong, M.D., +86-188-0179-0469, zoemodi@outlook.com
Yawei Xu, M.D., Ph.D.
About this study
Official title: Prognostic Implications of Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation at Shanghai Tenth People's Hospital
The prognostic implication of left atrial appendage occlusion (LAAO) procedure in non-valvular atrial fibrillation (NVAF) patients from China is still unclear. We aim to investigate the impact of LAAO procedure on subsequent clinical outcomes in patients from China.
Read the detailed description
Although the left atrial appendage occlusion (LAAO) procedure has increasingly been performed to prevent the occurrence of ischemic stroke events among patients with non-valvular atrial fibrillation (NVAF), the clinical benefits and prognostic implications of which have not been well characterized in patients from China. As a result, we aim to conduct an observational study to explore the prognostic impact of LAAO in patient with NVAF who are hospitalized in Shanghai Tenth People's Hospital.
- Being tested
- left atrial appendage occlusion devices
- Keywords
- atrial fibrillation; left atrial appendage occlusion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left atrial appendage occlusion devicesDevice
All NVAF patients who are admitted for receiving left atrial appendage occlusion procedure, including Watchman, LAmbre, Lefort, and Leftear deveices.
| Study group | Role | What they receive |
|---|---|---|
| Left atrial appendage occlusion | Patients with non-valvular atrial fibrillation who have received left atrial appendage occlusion procedure. Receives: Device: left atrial appendage occlusion devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular and cerebral events (MACCE)
A composite of all-cause death, ischemic stroke, heart failure rehospitalization and major bleeding events
Measured: From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years
Secondary outcomes (6)
All-cause death
Death from any cause
Measured: From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years
Cardiovascular death
Death from cardiovascular causes
Measured: From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years
Ischemic stroke
Ischemic stroke is defined as the presence of a new focal neurologic deficit thought to be ischemia in origin, with signs or symptoms lasting>24h
Measured: From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years
Major bleeding
The incidence of major bleeding as defined by BARC (3-5)
Measured: From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years
Heart failure rehospitalization
Rehospitalization for heart failure
Measured: From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years
Pericardial effusion
Pericardial effusion validated by echocardiography
Measured: From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start1 May 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yawei Xu, M.D., Ph.D., Principal investigator, Department of Cardiology, Shanghai Tenth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987945
- Sponsor's protocol ID
- LAAO-SH
- Acronym
- LAAO-SH
- Status last verified
- Jun 2019
- First submitted
- 14 Jun 2019
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Implications of Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation at Shanghai Tenth People's Hospital
- ClinicalTrials.gov ID
- NCT03987945
- Acronym / sponsor ID
- LAAO-SH / LAAO-SH
- Keywords
- atrial fibrillation; left atrial appendage occlusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 17 Jun 2019 (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.
The prognostic implication of left atrial appendage occlusion (LAAO) procedure in non-valvular atrial fibrillation (NVAF) patients from China is still unclear. We aim to investigate the impact of LAAO procedure on subsequent clinical outcomes in patients from China.
Detailed description
Although the left atrial appendage occlusion (LAAO) procedure has increasingly been performed to prevent the occurrence of ischemic stroke events among patients with non-valvular atrial fibrillation (NVAF), the clinical benefits and prognostic implications of which have not been well characterized in patients from China. As a result, we aim to conduct an observational study to explore the prognostic impact of LAAO in patient with NVAF who are hospitalized in Shanghai Tenth People's Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Left atrial appendage occlusion | – | Device: left atrial appendage occlusion devicesPatients with non-valvular atrial fibrillation who have received left atrial appendage occlusion procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with NVAF who are referred for LAAO procedure.
Key inclusion criteria (2 listed)
- Patients who were admitted for NVAF undergoing LAAO procedure between January 2014 and December 2017 in the Cardiology Department of Shanghai Tenth People's Hospital;
- Adult patients (>18 years old).
Key exclusion criteria (4 listed)
- Patients with rheumatic valvular disease;
- Patients with sick sinus syndrome;
- Patients who had a history of cardiac surgery (i.e., CABG);
- patients who had received the catheter radiofrequency ablation procedure.
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 |
|---|---|---|
| left atrial appendage occlusion devicesAll NVAF patients who are admitted for receiving left atrial appendage occlusion procedure, including Watchman, LAmbre, Lefort, and Leftear deveices. | Device | Left atrial appendage occlusion |
Primary outcome
Major adverse cardiovascular and cerebral events (MACCE)
Time frame: From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years
A composite of all-cause death, ischemic stroke, heart failure rehospitalization and major bleeding events
6 secondary outcomes
All-cause death
Time frame: From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years
Cardiovascular death
Time frame: From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years
Ischemic stroke
Time frame: From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years
Major bleeding
Time frame: From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years
Heart failure rehospitalization
Time frame: From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years
Pericardial effusion
Time frame: From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
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.
Yawei Xu, M.D., Ph.D. principal investigator
Department of Cardiology, Shanghai Tenth People's Hospital
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 Atrial Fibrillation and Left Atrial Appendage Occlusion, run by Shanghai 10th People's Hospital 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 2 inclusion and 4 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 17 Jun 2019. 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 Mengmeng Gong, M.D. (+86-188-0179-0469, zoemodi@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular and cerebral events (MACCE) (time frame: From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years). 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 17 Jun 2019.