Atrial FibrillationCLACBACNCT04185142
Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Population
An observational study of Atrial Fibrillation, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Cryoablation combined with left atrial appendage closure is a novel strategy for atrial fibrillation patients. Through long-term follow-up, the investigators aimed to observe the safety and efficacy of the combined procedure in Chinese population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- cryoballoon ablation combining with left atrial appendage closure
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2015to 16 Nov 2024
- 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: Chinese with documented non-valvular atrial fibrillation who meet the inclusion criteria while without any of the exclusion criteria.
Who may be able to join
- CHA2DS2-VASc score≥2 or HAS-BLED score≥3,
- having contraindications to long-term oral anticoagulants (OACs),
- refuse OAC therapy despite explanation.
Who cannot join
- thrombus in left atrium (LA) or left atrial appendage (LAA) presented and confirmed by transoesophageal echocardiograph (TEE),
- oversized LA (LA diameter>65mm by TTE) or LAA (LAA opening>35mm) through TEE,
- pericardial effusion (≥4mm by TTE or TEE),
- hemodynamic unstable patients,
- patients with active hemorrhagic diseases,
- ischemic or hemorrhagic stroke within 30 days.
Trial locations and contacts
1 site in 1 country.
Dongdong Zhao, MD, PhD contact
China1 site, 1 recruiting
- Recruiting
Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Zhongyuan Ren, MD, +8618862186450, cloudyrzy@gmail.com
Dongdong Zhao, MD, PhD, 249620601@163.com
About this study
Official title: Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Atrial Fibrillation Population
Cryoablation combined with left atrial appendage closure is a novel strategy for atrial fibrillation patients. Through long-term follow-up, the investigators aimed to observe the safety and efficacy of the combined procedure in Chinese population.
Read the detailed description
the investigators aimed to observe the clinical outcome of combining cryoballoon ablation (CBA) with left atrial appendage closure (LAAC) in drug-refractory non-valvular atrial fibrillation patients, who have high risk of stroke or hemorrhage, or contraindication of long-term oral anticoagulants (OACs).
The combined procedure was completed using CBA following LAAC. Generally, 3-month OACs, following 3-month double antiplatelet therapy, and lifelong single platelet therapy was recommended as antithrombotic regimen.
At 3rd,6th,12th and every year after since the procedure, Holter and transoesophageal echocardiography monitoring, and outpatient follow-up was applied to every patient.
The safety was evaluated by all-cause mortality, peri- and postprocedural complications. While the efficacy was evaluated through the freedom of atrial arrhythmia, stroke incidence, and withdrawal of OACs.
- Conditions
- Atrial Fibrillation
- Being tested
- cryoballoon ablation combining with left atrial appendage closure
- Keywords
- Combined procedure, Cryoballoon ablation, Left atrial appendage closure, Chinese
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryoballoon ablation combining with left atrial appendage closureCombination product
cryoballoon ablation using either 1st or 2nd generation of cryoballoon and left atrial appendage closure using devices including WATCHMAN, Lefort and Lacbes.
| Study group | Role | What they receive |
|---|---|---|
| combined procedure group | patients underwent cryoballoon ablation and left atrial appendage closure Receives: Combination Product: cryoballoon ablation combining with left atrial appendage closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial arrhythmia
The proportion of patients have recurrent atrial arrhythmia, including atrial tachycardia lasting longer than 30 seconds, atrial flutter, and atrial fibrillation. Detected by either ECG or 24 Holter monitor.
Measured: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Incidence of stroke
the proportion of patients have either hemorrhagic or ischemic stroke confirmed by CT or MRI.
Measured: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Secondary outcomes (13)
All-cause death
Death event due to any cause
Measured: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Cardiovascular death
death due to cardiovascular cause
Measured: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Major hemorrhagic events
Intracranial hemorrhage, gastrointestinal bleeding, or any overt bleeding with hemoglobin drop ≥3 to 5 g/dL.
Measured: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Myocardial infarction
Diagnosed myocardial infarction with or without ST segment elevation.
Measured: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Peripheral vascular embolism
Arterial or venous thrombosis except cardiac or cerebral vascular embolism confirmed by imaging examination.
Measured: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Rehospitalization due to cardiovascular events
Inpatient admission or emergency department admission with cardiovascular causes.
Measured: Since the start of the procedure to 5 years.
Redo-ablation
Ablation intended to treat recurrent atrial arrhythmia
Measured: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Withdrawal of oral anticoagulants
The proportion of patients stop oral anticoagulation therapy including warfarin, dabigatran, or rivaroxaban.
Measured: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Residual flow
Residual flow between LAAC device and LAA measured by TEE
Measured: Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result.
LAAC device position
displacement of LAAC device evaluated by TEE
Measured: Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result.
Device related thrombus
Thrombus surrounding or attached to the LAAC device detected by TEE
Measured: Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result.
Atrioesophageal fistula
Fistula between left atrium and esophagus detected by TEE.
Measured: Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result.
Pericardial effusion
Any amount of pericardial effusion detected by TTE or TEE
Measured: Since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start16 Oct 2015
- Primary completion16 Nov 2023 (estimated)
- Study completion16 Nov 2024 (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 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, MD, PhD, Principal investigator, Department of Cardiology, Shanghai Tenth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185142
- Sponsor's protocol ID
- CLACBAC
- Acronym
- CLACBAC
- Status last verified
- Sep 2022
- First submitted
- 25 Nov 2019
- Last updated
- 3 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ren Z, Zheng Y, Zhang J, Yang H, Wu J, Li H, Guo R, Meng W, Zhang J, Sun H, Xu Y, Zhao D. Patients With Larger Left Atrial Appendage Orifice Presented Worse Prognosis Contributed by Acute Heart Failure After Left Atrial Appendage Closure. J Am Heart Assoc. 2022 Sep 20;11(18):e026309. doi: 10.1161/JAHA.122.026309. Epub 2022 Sep 14.
PubMed 36102232
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Atrial Fibrillation Population
- ClinicalTrials.gov ID
- NCT04185142
- Acronym / sponsor ID
- CLACBAC / CLACBAC
- Conditions
- Atrial Fibrillation
- Keywords
- Combined procedure, Cryoballoon ablation, Left atrial appendage closure, Chinese
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 16 Oct 2015 (actual)
- Primary completion
- 16 Nov 2023 (estimated)
- Study completion
- 16 Nov 2024 (estimated)
- First posted
- 4 Dec 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.
Cryoablation combined with left atrial appendage closure is a novel strategy for atrial fibrillation patients. Through long-term follow-up, the investigators aimed to observe the safety and efficacy of the combined procedure in Chinese population.
Detailed description
the investigators aimed to observe the clinical outcome of combining cryoballoon ablation (CBA) with left atrial appendage closure (LAAC) in drug-refractory non-valvular atrial fibrillation patients, who have high risk of stroke or hemorrhage, or contraindication of long-term oral anticoagulants (OACs).
The combined procedure was completed using CBA following LAAC. Generally, 3-month OACs, following 3-month double antiplatelet therapy, and lifelong single platelet therapy was recommended as antithrombotic regimen.
At 3rd,6th,12th and every year after since the procedure, Holter and transoesophageal echocardiography monitoring, and outpatient follow-up was applied to every patient.
The safety was evaluated by all-cause mortality, peri- and postprocedural complications. While the efficacy was evaluated through the freedom of atrial arrhythmia, stroke incidence, and withdrawal of OACs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| combined procedure group | – | Combination Product: cryoballoon ablation combining with left atrial appendage closurepatients underwent cryoballoon ablation and left atrial appendage closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese with documented non-valvular atrial fibrillation who meet the inclusion criteria while without any of the exclusion criteria.
Key inclusion criteria (3 listed)
- CHA2DS2-VASc score≥2 or HAS-BLED score≥3,
- having contraindications to long-term oral anticoagulants (OACs),
- refuse OAC therapy despite explanation.
Key exclusion criteria (6 listed)
- thrombus in left atrium (LA) or left atrial appendage (LAA) presented and confirmed by transoesophageal echocardiograph (TEE),
- oversized LA (LA diameter>65mm by TTE) or LAA (LAA opening>35mm) through TEE,
- pericardial effusion (≥4mm by TTE or TEE),
- hemodynamic unstable patients,
- patients with active hemorrhagic 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 |
|---|---|---|
| cryoballoon ablation combining with left atrial appendage closurecryoballoon ablation using either 1st or 2nd generation of cryoballoon and left atrial appendage closure using devices including WATCHMAN, Lefort and Lacbes. | Combination product | combined procedure group |
Primary outcome
Recurrence of atrial arrhythmia
Time frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
The proportion of patients have recurrent atrial arrhythmia, including atrial tachycardia lasting longer than 30 seconds, atrial flutter, and atrial fibrillation. Detected by either ECG or 24 Holter monitor.
Incidence of stroke
Time frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
the proportion of patients have either hemorrhagic or ischemic stroke confirmed by CT or MRI.
13 secondary outcomes
All-cause death
Time frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Cardiovascular death
Time frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Major hemorrhagic events
Time frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Myocardial infarction
Time frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Peripheral vascular embolism
Time frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Rehospitalization due to cardiovascular events
Time frame: Since the start of the procedure to 5 years.
Redo-ablation
Time frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Withdrawal of oral anticoagulants
Time frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Residual flow
Time frame: Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result.
LAAC device position
Time frame: Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result.
Device related thrombus
Time frame: Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result.
Atrioesophageal fistula
Time frame: Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result.
Pericardial effusion
Time frame: Since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Derived from this study: PubMed 36102232Ren Z, Zheng Y, Zhang J, Yang H, Wu J, Li H, Guo R, Meng W, Zhang J, Sun H, Xu Y, Zhao D. Patients With Larger Left Atrial Appendage Orifice Presented Worse Prognosis Contributed by Acute Heart Failure After Left Atrial Appendage Closure. J Am Heart Assoc. 2022 Sep 20;11(18):e026309. doi: 10.1161/JAHA.122.026309. Epub 2022 Sep 14.
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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.
Dongdong Zhao, MD, PhD contact
Yawei Xu, MD, PhD 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, 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 3 inclusion and 6 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 3 Oct 2022. 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 Zhongyuan Ren, MD (+86 18862186450, cloudyrzy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of atrial arrhythmia (time frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.). 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?
On the ClinicalTrials.gov record for NCT04185142, 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 3 Oct 2022.