RecruitingACTRN12614000050651

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

Sponsor

Dr L Sanders

Enrollment

20 participants

Start Date

Feb 14, 2014

Study Type

Interventional

Conditions

Atrial fibrillation in cardiac surgery patients

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

Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study is collecting data on patients who have atrial fibrillation (AF) — an irregular heart rhythm — and are having heart surgery for another reason (such as a valve repair). During that surgery, a device called the AtriClip is used to close off a small pouch in the heart called the left atrial appendage (LAA). The LAA is a common source of blood clots that can cause stroke in people with AF. Researchers want to track how well the AtriClip closes the LAA. You may be eligible if: - You are having heart surgery for another condition - You also have atrial fibrillation You may NOT be eligible if: - You are having redo heart surgery (a repeat operation on the same area) - You have a blood clot inside the left atrial appendage - You have an allergy to nickel-titanium alloy (nitinol) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

Locations(1)

Sir Charles Gairdner Hospital - Nedlands

WA, Australia

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ACTRN12614000050651