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

Tongji University

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Combination Product: cryoballoon ablation combining with left atrial appendage closure

Study type: Observational

Funder types: Other

Identifiers

NCT04185142

CLACBAC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

150 participants in 1 patient group

combined procedure group

Description:

patients underwent cryoballoon ablation and left atrial appendage closure

Treatment:

Combination Product: cryoballoon ablation combining with left atrial appendage closure