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
ClinicalTrials.gov number: NCT02699957
CMS Approval Date: 08/17/2016

 

Clinical Study Approvals

Sponsor: Boston Scientific
Study Name: WATCHMAN FLX versus NOAC for embolic Protection in the management of patients with Non-Valvular Atrial Fibrillation (CHAMPION-AF)
NCT#: NCT04394546
IDE#: G200106
Approval Date: 12/14/2020

Study Title: Clinical trial of atrial fibrillation patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants (CATALYST Trial)
Sponsor Name: Abbott Medical Devices
NCT #: NCT04226547
IDE #: G190285
Approval date: 07/23/2020

Study Title: Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation (OPTION)
Sponsor: Cleveland Clinic
ClinicalTrials.gov 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
ClinicalTrials.gov Number: NCT02928497
Investigational Device Exemption (IDE) Number: G160171
CMS Approval Date:  12/5/2016

Page Last Modified:
12/22/2020 07:13 AM