Percutaneous Left Atrial Appendage Closure (LAAC)

Patients with atrial fibrillation (AF), an irregular heartbeat, are at an increased risk of stroke. The left atrial appendage (LAA) is a tubular structure that opens into the left atrium and has been shown to be one potential source for blood clots that can cause strokes. While thinning the blood with anticoagulant medications has been proven to prevent strokes, percutaneous LAAC has been studied as a non-pharmacologic alternative for patients with non-valvular AF who are at high risk for stroke.

CMS issued a Medicare National Coverage Determination (NCD) on February 8, 2016 which allows for coverage of LAAC under Coverage with Evidence Development (CED) with certain conditions. The complete determination is available on our website.

Decision Memo

Registry Approvals:

Left Atrial Appendage Occlusion (LAAO) Registry
Sponsor: American College of Cardiology number: NCT02699957
CMS Approval Date: 08/17/2016

Clinical Study Approvals

Study Title: Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation (OPTION)
Sponsor: Cleveland Clinic Number: NCT03795298
Investigational Device Exemption (IDE) Number: G180270
CMS Approval Date: 05/14/2019

Study Title:  Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO)
Sponsor: Boston Scientific Number: NCT02928497
Investigational Device Exemption (IDE) Number: G160171
CMS Approval Date:  12/5/2016

Page Last Modified:
05/29/2019 06:28 AM