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Trial record 1 of 1 for:    CLACBAC
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Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Population (CLACBAC)

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ClinicalTrials.gov Identifier: NCT04185142
Recruitment Status : Recruiting
First Posted : December 4, 2019
Last Update Posted : October 3, 2022
Sponsor:
Information provided by (Responsible Party):
Ya-Wei Xu, Shanghai 10th People's Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Atrial Fibrillation Combination Product: cryoballoon ablation combining with left atrial appendage closure

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
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Atrial Fibrillation Population
Actual Study Start Date : October 16, 2015
Estimated Primary Completion Date : November 16, 2023
Estimated Study Completion Date : November 16, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
combined procedure group
patients underwent cryoballoon ablation and left atrial appendage closure
 Combination Product: cryoballoon ablation combining with left atrial appendage closure
cryoballoon ablation using either 1st or 2nd generation of cryoballoon and left atrial appendage closure using devices including WATCHMAN, Lefort and Lacbes.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. All-cause death [ Time Frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    Death event due to any cause

  2. Cardiovascular death [ Time Frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    death due to cardiovascular cause

  3. Major hemorrhagic events [ Time Frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    Intracranial hemorrhage, gastrointestinal bleeding, or any overt bleeding with hemoglobin drop ≥3 to 5 g/dL.

  4. Myocardial infarction [ Time Frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    Diagnosed myocardial infarction with or without ST segment elevation.

  5. Peripheral vascular embolism [ Time Frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    Arterial or venous thrombosis except cardiac or cerebral vascular embolism confirmed by imaging examination.

  6. Rehospitalization due to cardiovascular events [ Time Frame: Since the start of the procedure to 5 years. ]
    Inpatient admission or emergency department admission with cardiovascular causes.

  7. Redo-ablation [ Time Frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    Ablation intended to treat recurrent atrial arrhythmia

  8. Withdrawal of oral anticoagulants [ Time Frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    The proportion of patients stop oral anticoagulation therapy including warfarin, dabigatran, or rivaroxaban.

  9. 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. ]
    Residual flow between LAAC device and LAA measured by TEE

  10. 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. ]
    displacement of LAAC device evaluated by TEE

  11. 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. ]
    Thrombus surrounding or attached to the LAAC device detected by TEE

  12. 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. ]
    Fistula between left atrium and esophagus detected by TEE.

  13. Pericardial effusion [ Time Frame: Since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. ]
    Any amount of pericardial effusion detected by TTE or TEE


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese with documented non-valvular atrial fibrillation who meet the inclusion criteria while without any of the exclusion criteria.
Criteria

Drug refractory non-valvular paroxysmal atrial fibrillation patients,

Inclusion Criteria:

  1. CHA2DS2-VASc score≥2 or HAS-BLED score≥3,
  2. having contraindications to long-term oral anticoagulants (OACs),
  3. refuse OAC therapy despite explanation.

Exclusion Criteria:

  1. thrombus in left atrium (LA) or left atrial appendage (LAA) presented and confirmed by transoesophageal echocardiograph (TEE),
  2. oversized LA (LA diameter>65mm by TTE) or LAA (LAA opening>35mm) through TEE,
  3. pericardial effusion (≥4mm by TTE or TEE),
  4. hemodynamic unstable patients,
  5. patients with active hemorrhagic diseases,
  6. ischemic or hemorrhagic stroke within 30 days.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185142


Contacts
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Contact: Zhongyuan Ren, MD +86 18862186450 cloudyrzy@gmail.com
Contact: Dongdong Zhao, MD, PhD 249620601@163.com

Locations
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China, Shanghai
Department of Cardiology, Shanghai Tenth People's Hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact: Zhongyuan Ren, MD    +8618862186450    cloudyrzy@gmail.com   
Contact: Dongdong Zhao, MD, PhD       249620601@163.com   
Principal Investigator: Yawei Xu, MD, PhD         
Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
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Principal Investigator: Yawei Xu, MD, PhD Department of Cardiology, Shanghai Tenth People's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ya-Wei Xu, Chief physician, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT04185142    
Other Study ID Numbers: CLACBAC
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: October 3, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ya-Wei Xu, Shanghai 10th People's Hospital:
Combined procedure
Cryoballoon ablation
Left atrial appendage closure
Chinese
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes