Evaluation of the AtriClip for completeness of left atrial appendage closure in cardiac surgery patients with concomitant atrial fibrillation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000050651

Enrollment

Registered

2014-01-17

Start date

2014-02-14

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The left atrial appendage (LAA) is the most common source of thrombus in patients with atrial fibrillation (AF). Such thrombus has the potential to embolise to the brain, causing stroke. Ligation of the appendage is a commonly performed concomitant procedure in patients with AF undergoing heart surgery for other reasons . Current literature suggests that complete exclusion of the left atrial appendage occurs in only 40% of patients undergoing ligation and intra-atrial closure. A small amount of data suggests better long term exclusion of the LAA with the Atriclip device. In addition there is little risk of bleeding compare to excision and oversewing. We would like to collect data on patients undergoing left atrial appendage ligation using the Atriclip device

Interventions

Left atrial appendage closure with AtriClip LAA exclusion system. The AtriClip is a polyester fabric covered titanium clip. It is placed with the use of an applicator and adds about 5 to 10 minutes to the cardiac surgical procedure time

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Cardiac surgery patients with concomitant atrial fibrillation

Exclusion criteria

Redo surgery patients, Left atrial appendage thrombus, nickle-titanium alloy or nitinol allergy

Outcome results