Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Population

Atrial Fibrillation Clinical Trial

— CLACBAC  

Official title:

Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Atrial Fibrillation Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04185142
• Other study ID #: CLACBAC
• Status: Recruiting
• Start date: October 16, 2015
• Est. completion date: November 16, 2024

Study information

• Verified date: September 2022
• Source: Shanghai 10th People's Hospital
• Contact: Zhongyuan Ren, MD
• Phone: +86 18862186450
• Email: cloudyrzy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 16, 2024
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
China	Department of Cardiology, Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Rehospitalization due to cardiovascular events	Inpatient admission or emergency department admission with cardiovascular causes.	Since the start of the procedure to 5 years.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.