Safety and Effectiveness of Left Atrial Appendage Occlusion

Conditions

Atrial Fibrillation

Brief summary

This study is to evaluate acute and long-term safety and effectiveness of Left atrial appendage occlusion (LAA)with the AtriCure LAA Occlusion System. This device will be applied in patients with atrial fibrillation (AF), paroxysmal, persistent and permanent, undergoing cardiac surgery with a concomitant Maze/Ablation procedure.

Cong Ye, Xuesong Han, Yiming Chen, Fei Liu, Hao Ma et al. (11 authors)

BMJ Open2022-10-012 citations

10.1136/bmjopen-2022-063931

Epicardial left atrial appendage AtriClip occlusion reduces the incidence of stroke in patients with atrial fibrillation undergoing cardiac surgery

Etem Caliskan, Ayhan Şahin, Murat Yılmaz, Burkhardt Seifert, Ricarda Hinzpeter et al. (15 authors)

EP Europace2017-07-18110 citations

10.1093/europace/eux211

Safe, effective and durable epicardial left atrial appendage clip occlusion in patients with atrial fibrillation undergoing cardiac surgery: first long-term results from a prospective device trial.

Emmert MY, Puippe G, Baumüller S, Alkadhi H, Landmesser U, Plass A, Bettex D, Scherman J, Grünenfelder J, Genoni M, Falk V, Salzberg SP.

2013-05-08101 citations

10.1093/ejcts/ezt204

Interventions

DEVICEAtriCure LAA Exclusion System

Placement of clip of LAA.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1. Documented history (paroxysmal, persistent or permanent) of AF \[one episode within the last 12 months of enrollment\] 2. Elective Maze procedure 3. Suitable anatomy 4. Able and willing to sign informed consent 5. Age over 18 years

Exclusion criteria

1. Patient from Intensive Care Unit with either: 1. intra-venous catecholamines 2. ventilator 3. cardiac index \<1.8 l/min. 2. Reoperative Cardiac Surgery 3. Systemic or Inflammatory disease 4. Dialysis 5. Recent myocardial infarction (\< 21 days) 6. History of pericarditis 7. Patient taking part in any other device or drug study 8. Patient with known sensitivity or allergy to any of the device components 9. Pregnancy

Design outcomes

Primary

Measure	Time frame
Safety - Device related complications	30 days
Efficacy - Occlusion of the LAA	6 months

Countries

Switzerland

Outcome results

None listed