Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Population (CLACBAC)

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Zhongyuan Ren, MD; Phone Number: +86 18862186450; Email: cloudyrzy@gmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Recruiting
      • Department of Cardiology, Shanghai Tenth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	Death event due to any cause	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	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.	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.	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.	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.	Since the start of the procedure to 5 years.
Redo-ablation	Ablation intended to treat recurrent atrial arrhythmia	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.	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	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	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	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.	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	Since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Principal Investigator: Yawei Xu, MD, PhD, Department of Cardiology, Shanghai Tenth People's Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 16, 2015
• Primary Completion (ANTICIPATED): November 16, 2023
• Study Completion (ANTICIPATED): November 16, 2024

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: November 30, 2019
• First Posted (ACTUAL): December 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Chinese; Cryoballoon ablation; Left atrial appendage closure; Combined procedure
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CLACBAC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No