Non-paroxysmal Atrial FibrillationNCT06021808
LAA Clipping Versus NOACs to Prevent Stroke in Non-paroxysmal Atrial Fibrillation.
A study testing Thoracoscopic LAA clipping and Novel oral anticoagulant in people with Non-paroxysmal Atrial Fibrillation, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This trial is designed to examine the hypothesis that thoracoscopic LAA clipping is superior to NOACs for stroke, systemic embolism, all-cause mortality, major bleeding events and clinically relevant nonmajor bleeding events in AF patients at high risk of embolism (CHA2DS2-VASc ≥2 in men and ≥3 in women) that are not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-paroxysmal Atrial Fibrillation
- What is being tested?
- Thoracoscopic LAA clipping and Novel oral anticoagulant
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2024to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥ 18 years.
- Persistent or long-standing persistent AF documented by medical history or direct electrocardiogram.
- CHA2DS2-VASc ≥2 in men and ≥3 in women.
- Agree to perform thoracoscopic LAA occlusion procedure.
Who cannot join
- With electrical cardioversion or ablation intent.
- Other heart diseases with surgical indications.
- Ischemic stroke and other cardiac embolic events within 30 days.
- Major clinical bleeding event within 30 days.
- Contraindications to anticoagulation.
- Intracardiac thrombus.
Show all 22Show fewer
- Left ventricular ejection fraction (LVEF) < 30%.
- Active systemic infection or infective endocarditis or pericarditis
- Severe liver disease (acute clinical hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT)/ aspartate transaminase (AST) greater than 3 times the upper limit of normal value.
- Severe renal insufficiency (eGFR ≤ 30mL/min).
- Other diseases requiring oral anticoagulants.
- Active aortic plaque.
- Acute coronary syndrome within 3 months.
- Symptomatic carotid artery stenosis.
- Patients requiring dual antiplatelet drug therapy.
- Previous cardiac and left lung surgery.
- Severe left pleural and pericardial adhesions.
- Pregnant or breastfeeding patients.
- Metal allergies.
- Terminal illness with a life expectancy of less than 2 years.
- Participation in other clinical studies at the time of enrollment.
- Refuse to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chunyu Yu, MD contact
China1 site, 1 recruiting
- Recruiting
China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
Zhe Zheng, M.D., Ph.D., 8610-8839-6051, zhengzhe@fuwai.com
Chunyu Yu, MD, yuchunyu@fuwai.com
About this study
Official title: Epicardial Left Atrial Appendage Clipping Versus Novel Oral Anticoagulants to Reduce Stroke Risk in Non-paroxysmal Atrial Fibrillation: a Multicenter Randomized Controlled Trial
This trial is designed to examine the hypothesis that thoracoscopic LAA clipping is superior to NOACs for stroke, systemic embolism, all-cause mortality, major bleeding events and clinically relevant nonmajor bleeding events in AF patients at high risk of embolism (CHA2DS2-VASc ≥2 in men and ≥3 in women) that are not undergoing ablation.
Read the detailed description
Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia disease, and the incidence of AF increases markedly with age and approximately doubles with each decade. According to the previous study, the incidence of stroke were five times in patients with AF than those in the general population. Systemic oral anticoagulant is a well-established, guideline-recommended therapy for the prevention of ischemic stroke in patients with nonvalvular AF at high risk of embolism (CHA2DS2-VASc scores ≥2 in men and ≥3 in women), and the guidelines recommend that the novel oral anticoagulants (NOACs) be preferred (Class I, Level of evidence A). However, a significant proportion of patients with nonvalvular AF have difficulties in long-term oral anticoagulant therapy, due to medication adherence and contraindications to oral anticoagulants. Also, several randomized controlled trials indicated that bleeding risk remained high with novel oral anticoagulants. Therefore, it is essential to explore alternative treatment strategies for stroke prevention in patients with nonvalvular AF.
It has been reported that the left atrial appendage (LAA) is suspected as a vital source of cerebral emboli and may lead to ischemic stroke, removal or closure of the LAA may be an alternative to oral anticoagulants. Various surgical or interventional approaches have been developed to close or occlude LAA to prevent stroke in AF patients, such as percutaneous LAA occlusion, suture ligation, and surgical excision. However, these techniques suffer from incomplete LAA closure or the presence of residual blood flow, which can lead to thrombosis and stroke. Thoracoscopic LAA clip, on the other hand, cloud block blood flow between the LAA and the left atrium (LA), achieving isolation of LAA and preventing thrombi and strokes. A previous study has demonstrated a high 95% success rate of LAA clipping without operation-related complications, and freedom from stroke was 99.1% at a median follow-up of 20 months. Therefore, LAA clipping is an effective and durable method in stroke prevention. However, currently high-quality RCTs are lacking to support the superiority of LAA clipping compared with NOACs in terms of stroke prevention and safety. In this trial, the investigators designed a multicenter prospective RCT to compare the efficacy and safety of thoracoscopic LAA clipping and NOACs in patients with non-paroxysmal AF.
- Conditions
- Non-paroxysmal Atrial Fibrillation
- Being tested
- Thoracoscopic LAA clipping, Novel oral anticoagulant
- Keywords
- left atrial appendage clipping, Stroke, Oral anticoagulation, Atrial Fibrillation
- Medical subject headings
- Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracoscopic LAA clippingProcedure or surgery
The surgeons measured the length of the base of the LAA, an appropriately sized LAA clip is then inserted with the aid of a thoracoscope and placed parallel to the base of the LAA.
Novel oral anticoagulantDrug
For patients with creatinine clearance ≥50 ml/min, oral rivaroxaban 20 mg daily was administered, whereas for patients with creatinine clearance between 30-49 ml/min, oral rivaroxaban 15 mg daily was administered.
| Study group | Role | What they receive |
|---|---|---|
| LAA clipping group | Experimental | In this arm, participants are performed thoracoscopic LAA clipping. Receives: Procedure: Thoracoscopic LAA clipping |
| NOACs group | Active comparator | Patients randomized to NOAC therapy will begin long-term oral administration of NOACs immediately after enrollment. Receives: Drug: Novel oral anticoagulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of composite endpoint
Stroke, systemic embolism, all-cause mortality, major bleeding event, and clinically relevant non-major bleeding event.
Measured: At 24-month after intervention
Secondary outcomes (7)
Rate of stroke
Acute episodes of focal or global neurological dysfunction due to cerebral, spinal cord or retinal vascular injury from haemorrhage or infarction. Symptoms or signs must have lasted ≥ 24 hours, or symptoms/signs may have lasted less than 24 hours if demonstrated by CT, MRI, or autopsy.
Measured: At 24-month after intervention
Rate of systemic embolism
Confirmed by imaging or angiography
Measured: At 24-month after intervention
Rate of all-cause mortality
Deaths from all causes
Measured: At 24-month after intervention
Rate of major bleeding event
- fatal haemorrhage, and/or
- Symptomatic haemorrhage in a critical area or organ, such as intracranial, intravertebral, intraocular, retroperitoneal, intra-articular or intrapericardial, or intramuscular haemorrhage leading to osteofascial compartment syndrome, and/or 3. haemorrhage that results in a fall in haemoglobin level of 2.0 g/dL or more, or that results in the importation of two or more units of whole blood or red blood cells.
Measured: At 24-month after intervention
Rate of clinically relevant non-major bleeding event
Bleeding events that do not meet the criteria for an ISTH major bleeding event but requires hospitalisation or a change in antithrombotic treatment strategy or requires invasive management.
Measured: At 24-month after intervention
Rate of surgery-related complications
Incidence of in-hospital death, in-hospital stroke, intermediate small-incision open thoracotomy or median open thoracotomy, and postoperative re-intervention due to hemorrhage, pneumothorax, and pyothorax.
Measured: At 24-month after intervention
Rate of minor bleeding events
Bleeding events that do not meet the ISTH criteria for a major bleeding event, do not meet the criteria for a clinically relevant non-major bleeding event, and do not require the subject to seek additional assistance from medical care.
Measured: At 24-month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start2 Apr 2024
- Primary completionApr 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zhe Zheng, MD,PhD, Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021808
- Sponsor's protocol ID
- 2023-2059
- Status last verified
- Jun 2024
- First submitted
- 28 Aug 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu C, Li H, Lei C, Wang Y, Chen S, Zhao Y, Zheng Z. Epicardial left atrial appendage clipping versus direct oral anticoagulant to reduce stroke risk in non-paroxysmal atrial fibrillation (LAA-CLIP): rationale, design and study protocol for a multicentre randomised controlled trial. BMJ Open. 2024 Mar 5;14(3):e083153. doi: 10.1136/bmjopen-2023-083153.
PubMed 38448081
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epicardial Left Atrial Appendage Clipping Versus Novel Oral Anticoagulants to Reduce Stroke Risk in Non-paroxysmal Atrial Fibrillation: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06021808
- Acronym / sponsor ID
- 2023-2059
- Conditions
- Non-paroxysmal Atrial Fibrillation
- Keywords
- left atrial appendage clipping, Stroke, Oral anticoagulation, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 1 Sep 2023 (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 trial is designed to examine the hypothesis that thoracoscopic LAA clipping is superior to NOACs for stroke, systemic embolism, all-cause mortality, major bleeding events and clinically relevant nonmajor bleeding events in AF patients at high risk of embolism (CHA2DS2-VASc ≥2 in men and ≥3 in women) that are not undergoing ablation.
Detailed description
Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia disease, and the incidence of AF increases markedly with age and approximately doubles with each decade. According to the previous study, the incidence of stroke were five times in patients with AF than those in the general population. Systemic oral anticoagulant is a well-established, guideline-recommended therapy for the prevention of ischemic stroke in patients with nonvalvular AF at high risk of embolism (CHA2DS2-VASc scores ≥2 in men and ≥3 in women), and the guidelines recommend that the novel oral anticoagulants (NOACs) be preferred (Class I, Level of evidence A). However, a significant proportion of patients with nonvalvular AF have difficulties in long-term oral anticoagulant therapy, due to medication adherence and contraindications to oral anticoagulants. Also, several randomized controlled trials indicated that bleeding risk remained high with novel oral anticoagulants. Therefore, it is essential to explore alternative treatment strategies for stroke prevention in patients with nonvalvular AF.
It has been reported that the left atrial appendage (LAA) is suspected as a vital source of cerebral emboli and may lead to ischemic stroke, removal or closure of the LAA may be an alternative to oral anticoagulants. Various surgical or interventional approaches have been developed to close or occlude LAA to prevent stroke in AF patients, such as percutaneous LAA occlusion, suture ligation, and surgical excision. However, these techniques suffer from incomplete LAA closure or the presence of residual blood flow, which can lead to thrombosis and stroke. Thoracoscopic LAA clip, on the other hand, cloud block blood flow between the LAA and the left atrium (LA), achieving isolation of LAA and preventing thrombi and strokes. A previous study has demonstrated a high 95% success rate of LAA clipping without operation-related complications, and freedom from stroke was 99.1% at a median follow-up of 20 months. Therefore, LAA clipping is an effective and durable method in stroke prevention. However, currently high-quality RCTs are lacking to support the superiority of LAA clipping compared with NOACs in terms of stroke prevention and safety. In this trial, the investigators designed a multicenter prospective RCT to compare the efficacy and safety of thoracoscopic LAA clipping and NOACs in patients with non-paroxysmal AF.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAA clipping group | Experimental | Procedure: Thoracoscopic LAA clippingIn this arm, participants are performed thoracoscopic LAA clipping. |
| NOACs group | Active comparator | Drug: Novel oral anticoagulantPatients randomized to NOAC therapy will begin long-term oral administration of NOACs immediately after enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Persistent or long-standing persistent AF documented by medical history or direct electrocardiogram.
- CHA2DS2-VASc ≥2 in men and ≥3 in women.
- Agree to perform thoracoscopic LAA occlusion procedure.
Key exclusion criteria (22 listed)
- With electrical cardioversion or ablation intent.
- Other heart diseases with surgical indications.
- Ischemic stroke and other cardiac embolic events within 30 days.
- Major clinical bleeding event within 30 days.
- Contraindications to anticoagulation.
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 |
|---|---|---|
| Thoracoscopic LAA clippingThe surgeons measured the length of the base of the LAA, an appropriately sized LAA clip is then inserted with the aid of a thoracoscope and placed parallel to the base of the LAA. | Procedure or surgery | LAA clipping group |
| Novel oral anticoagulantFor patients with creatinine clearance ≥50 ml/min, oral rivaroxaban 20 mg daily was administered, whereas for patients with creatinine clearance between 30-49 ml/min, oral rivaroxaban 15 mg daily was administered. | Drug | NOACs group |
Primary outcome
Rate of composite endpoint
Time frame: At 24-month after intervention
Stroke, systemic embolism, all-cause mortality, major bleeding event, and clinically relevant non-major bleeding event.
7 secondary outcomes
Rate of stroke
Time frame: At 24-month after intervention
Rate of systemic embolism
Time frame: At 24-month after intervention
Rate of all-cause mortality
Time frame: At 24-month after intervention
Rate of major bleeding event
Time frame: At 24-month after intervention
Rate of clinically relevant non-major bleeding event
Time frame: At 24-month after intervention
Rate of surgery-related complications
Time frame: At 24-month after intervention
Rate of minor bleeding events
Time frame: At 24-month after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Derived from this study: PubMed 38448081Yu C, Li H, Lei C, Wang Y, Chen S, Zhao Y, Zheng Z. Epicardial left atrial appendage clipping versus direct oral anticoagulant to reduce stroke risk in non-paroxysmal atrial fibrillation (LAA-CLIP): rationale, design and study protocol for a multicentre randomised controlled trial. BMJ Open. 2024 Mar 5;14(3):e083153. doi: 10.1136/bmjopen-2023-083153.
- Individual participant dataSharing planned: No
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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.
Chunyu Yu, MD contact
Zhe Zheng, MD,PhD study chair
Chinese Academy of Medical Sciences, Fuwai 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 Thoracoscopic LAA clipping and Novel oral anticoagulant in people with Non-paroxysmal Atrial Fibrillation, run by China National Center for Cardiovascular 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 22 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: looking for participants now, as of the sponsor's last update on 13 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhe Zheng, MD,PhD (+86-010-88396051, zhengzhe@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of composite endpoint (time frame: At 24-month after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06021808, which also lists 1 linked publication.
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 13 Jun 2024.