Heart SurgeryNCT04108169
Association Between S-LAAO and Adverse Cardiovascular Events Among Patients Undergoing Coronary Artery Bypass Grafting.
A study testing Left atrial appendage occlusion surgery in people with Heart Surgery, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 1 site in China.
Trial summary
This is a prospective, single-center, randomized, active controlled, clinical trail to assess the efficacy and safety of surgical closure of left atrial appendage (LAA) in patients undergoing coronary artery bypass graft. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Surgery
- What is being tested?
- Left atrial appendage occlusion surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to Jan 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject undergoing coronary artery bypass grafting according to clinical indications;
- Age is more than 18 and less than 80 years old;
- Male and non pregnancy female;
- Subject understands study requirements and agrees to sign an informed consent from prior to study procedures.
Who cannot join
- Pregnancy female;
- Participate in other clinical trial in the last 1 month.
- Subject doesn't agree to sign an informed consent from prior to study procedures.
- Subject undergoing repeat CABG, concomitant valve or other cardiac surgery.
- New York Heart Association (NYHA) Class IV heart failure.
Trial locations and contacts
1 site in 1 country.
Ping Li, PHD contact
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, 100029
ke-xu Yang, 86-010-64426153, EC@anzhenGCP.com
About this study
Official title: A Chinese Registry to Evaluate the Association of Surgical Left Atrial Appendage Occlusion vs No Receipt of S-LAAO With Adverse Cardiovascular Events Among Petients Undergoing Coronary Artery Bypass Grafting.
This is a prospective, single-center, randomized, active controlled, clinical trail to assess the efficacy and safety of surgical closure of left atrial appendage (LAA) in patients undergoing coronary artery bypass graft.
- Conditions
- Heart Surgery
- Being tested
- Left atrial appendage occlusion surgery
- Keywords
- Coronary artery bypass graft, Left Atrial Appendage Occlusion, stroke, prevention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left atrial appendage occlusion surgeryProcedure or surgery
CABG according to indications in the current guidelines on myocardial revascularization including surgical closure of left atrial appendage
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | Not described Receives: Procedure: Left atrial appendage occlusion surgery |
| Sham Comparator | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
Measured: 3 year after discharge (These data is collected during follow-up visit at in-hospital)
Secondary outcomes (2)
Atrial fibrillation
Measured: 3 year after discharge (These data is collected during follow-up visit at in-hospital)
Composite of ischemic stroke, thromboembolism and all death
Measured: 3 year after discharge (These data is collected during follow-up visit at in-hospital)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart SurgeryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ping Li, PHD, Study director, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108169
- Sponsor's protocol ID
- 20190926
- Status last verified
- Sep 2019
- First submitted
- 26 Sep 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Chinese Registry to Evaluate the Association of Surgical Left Atrial Appendage Occlusion vs No Receipt of S-LAAO With Adverse Cardiovascular Events Among Petients Undergoing Coronary Artery Bypass Grafting.
- ClinicalTrials.gov ID
- NCT04108169
- Acronym / sponsor ID
- 20190926
- Conditions
- Heart Surgery
- Keywords
- Coronary artery bypass graft, Left Atrial Appendage Occlusion, stroke, prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel DiseasesUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 30 Sep 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.
This is a prospective, single-center, randomized, active controlled, clinical trail to assess the efficacy and safety of surgical closure of left atrial appendage (LAA) in patients undergoing coronary artery bypass graft.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Procedure: Left atrial appendage occlusion surgery |
| Sham Comparator | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject undergoing coronary artery bypass grafting according to clinical indications;
- Age is more than 18 and less than 80 years old;
- Male and non pregnancy female;
- Subject understands study requirements and agrees to sign an informed consent from prior to study procedures.
Key exclusion criteria (5 listed)
- Pregnancy female;
- Participate in other clinical trial in the last 1 month.
- Subject doesn't agree to sign an informed consent from prior to study procedures.
- Subject undergoing repeat CABG, concomitant valve or other cardiac surgery.
- New York Heart Association (NYHA) Class IV heart failure.
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 surgeryCABG according to indications in the current guidelines on myocardial revascularization including surgical closure of left atrial appendage | Procedure or surgery | Active Comparator |
Primary outcome
All-cause death
Time frame: 3 year after discharge (These data is collected during follow-up visit at in-hospital)
2 secondary outcomes
Atrial fibrillation
Time frame: 3 year after discharge (These data is collected during follow-up visit at in-hospital)
Composite of ischemic stroke, thromboembolism and all death
Time frame: 3 year after discharge (These data is collected during follow-up visit at in-hospital)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
Related trials for Heart Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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.
Ping Li, PHD contact
Ping Li, PHD study director
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left atrial appendage occlusion surgery in people with Heart Surgery, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases 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 4 inclusion and 5 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 30 Sep 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 Yulin Li, PHD (86-010-64426153, lyllyl_1111@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death (time frame: 3 year after discharge (These data is collected during follow-up visit at in-hospital)). 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 30 Sep 2019.