Clinical trial NCT04185142: Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Population
Official title: Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Atrial Fibrillation Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Combined procedure
Cryoballoon ablation
Left atrial appendage closure
Chinese
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Recurrence of atrial arrhythmia
timeFrame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
measure: Incidence of stroke
timeFrame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Secondary outcomes:
measure: All-cause death
timeFrame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
measure: Cardiovascular death
timeFrame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
measure: Major hemorrhagic events
timeFrame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
measure: Myocardial infarction
timeFrame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
measure: Peripheral vascular embolism
timeFrame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
measure: Rehospitalization due to cardiovascular events
timeFrame: Since the start of the procedure to 5 years.
measure: Redo-ablation
timeFrame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
measure: Withdrawal of oral anticoagulants
timeFrame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
measure: Residual flow
timeFrame: Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result.
measure: LAAC device position
timeFrame: Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result.
measure: Device related thrombus
timeFrame: Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result.
measure: Atrioesophageal fistula
timeFrame: Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result.
measure: Pericardial effusion
timeFrame: Since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Cardiology, Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Department of Cardiology, Shanghai Tenth People's Hospital
name: Yawei Xu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.