Table 1 Included patients, inclusion / exclusion criteria and demographic data

Chen et al. (2019) [21]

Open-label, non-randomized, prospective, single-center study

Safety, feasibility, and efficacy of LAAC with the LAmbre device in NVAF patients

NVAF, age > 18 years, CHA₂DS₂-VASc Score > 2, contraindication or intolerance to long-term OAC, refusal of OAC treatment, isolated noncontractile LAA after multiple

AF ablation procedures

clinical conditions not allowing TEE and sedation;

poor peripheral vessel access not allowing device delivery;

LAA thrombus (TEE);

LVEF< 30%;

patients with atrial septal occluder;

stroke or TIA in the past 30 d;

acute myocardial infarction or unstable angina;

decompensated heart failure (New York Heart Association functional class III–IV), or heart transplantation;

rheumatic, significant degenerative, or congenital valvular heart diseases, artificial heart valve replacement operation;

significant and unexplained pericardial effusion (≥4 cm²)

n = 30

(1 center; Germany)

77.6 ± 8.9

n = 15 /

50%

Feng et al. (2019) [22]

Open-label, non-randomized, prospective, single-center study

Safety, feasibility, and efficacy of LAAC with the LAmbre device in NVAF patients with or without prior ablation

NVAF, CHADS₂ Score > 1, contraindication for or failure of OAC

LAA orifice diameter < 12 mm;

LAA thrombus (TEE);

LVEF< 30%;

stroke or TIA in the past 30 d:

presence of thrombus in the heart;

prosthetic valve;

myocardial infarction or unstable angina;

acute infective endocarditis;

pregnancy;

symptomatic carotid artery disease;

malignancies with an estimated life expectancy of ≤2 years; allergy to nitinol

n = 17

(1 center; China)

71.4 ± 7.8

n = 7 /

41.2%

Reinsch et al. (2018) [19]

Retrospective analysis of single-center case series

Safety, feasibility, and efficacy of LAAC with the LAmbre device

NVAF, CHA₂DS₂-VASc Score > 2, HAS-BLED > 3, past bleeding

N/A

n = 11

(1 center; Germany)

72.6 ± 7.9

n = 7 /

63.6%

Park et al. (2018) [18]

Open-label, non-randomized, prospective, multicenter study

Safety, feasibility, and efficacy of LAAC with the LAmbre device

NVAF> 3 months, > 18 years age, CHA₂DS₂-VASc Score > 2, and contraindications for OAC

LAA orifice diameter < 12 mm or > 30 mm, LAA diameter > 65 mm, LAA thrombus (TEE);

LVEF< 30%, NYHA III or IV, prior heart transplantation;

heart rate > 110 beats per minute;

stroke or TIA in the past 30 d;

past LAAC or surgical LAA removal, past ASD closure;

rheumatic, degenerative or congenital valvular heart disease;

recent or acute myocardial infarction or unstable angina;

mechanical valve prosthesis;

scheduled electrophysiological ablation procedure, scheduled pharmacological or electrical cardioversion; pre-procedural pericardial effusion;

signs or symptoms of infection;

pregnancy or breastfeeding;

symptomatic carotid artery disease;

malignancies with an estimated life expectancy of ≤2 years;

allergy to nitinol, thrombocytopenia (platelet ≤100.000 per microliter);

complex atherosclerotic plaques (≥4 mm) in the ascending aorta

n = 60

(2 centers; Germany)

74.4 ± 9.0

n = 40 /

66.7%

Kleinecke et al. (2018) [17]

Open-label, non-randomized, multicenter observational study

Safety, feasibility, and efficacy of LAAC with the LAmbre device and the FuStar steerable sheath

Common indications for LAAC, patients` explicit choice

LAA thrombus (TEE); planed cardiac surgery; history of ASD closure;

endocarditis, active infections

n = 20

(2 centers; Germany)

76.6 ± 8.4

n = 12 /

60%

Cruz-Gonzalez et al. (2018) [20]

Open-label, non-randomized, prospective, multicenter observational registry

Safety and feasibility of LAAC with the LAmbre device

Common indications for LAAC

N/A

n = 7

(3 centers; Spain)

78.6 + 6.9

n = 3 /

42.9%

Chen et al. (2018) [9]

Open-label, non-randomized, prospective, single-center observational study

Safety, feasibility and efficacy of LAAC with the LAmbre device

Common indications for LAAC

N/A

n = 30

(1 center; Germany)

77.6 ± 8.9

n = 15 /

50.0%

Zhou et al. (2017) [16]

Open-label, non-randomized, prospective, single-center observational study

Value of 3D-TEE guidance of LAAC (LAmbre and Lefort)

NVAF, CHA₂DS₂-VASc Score > 2, contraindications for OAC

LAA thrombus (TEE); LVEF< 40%, NYHA IV; myocardial infarction within the last 3 months;

vascular abnormalities interfering with LAAC

n = 21

(1 center; China)

66.6 ± 8.5

n = 15 /

71.4%

Huang et al. (2017) [15]

Open-label, non-randomized, prospective, multicenter study (NCT02029014)

Safety, feasibility, and efficacy of LAAC with the LAmbre device

NVAF > 18 years age with CHADS₂ Score > 1 and not suitable for long term OAC/VKA

LAA orifice diameter < 12 mm;

LAA thrombus (TEE);

LVEF< 30%, NYHA IV;

stroke or TIA in the past 30 d;

past ASD closure;

infective endocarditis;

hemorrhagic disease;

pregnancy;

endocarditis;

prosthetic valve

n = 153

(12 centers; China)

69.3 +  9.4

n = 87 /

56.2%

Jie et al. (2016) [14]

Open-label, non-randomized, single-center observational study

Investigation on changes of ECG and echocardiographic parameters after LAAC

NVAF, history of previous bleeding, high risk of bleeding, inability to adhere with OAC

LAA orifice diameter < 12 mm or > 30 mm;

LAA thrombus (TEE);

LVEF< 30%;

mitral valve stenosis

n = 54

(1 center; Germany)

71.1 ± 9.1

n = 34 /

63.0%

Total /

Overall mean

403

73.6 + 4.0

n = 235 /

58.3%