Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06168942
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-03
First Post:
2023-12-05
Brief Title:
Laminar LAAX Pivotal IDE Study
Sponsor:
Laminar Inc
Organization:
Laminar Inc
Study Overview
Official Title:
Laminar Left Atrial Appendage Elimination LAAX Pivotal IDE Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare the Laminar Left Atrial Appendage Closure System to commercially available left atrial appendage closure devices This procedure is for patients with non-valvular atrial fibrillation who are at increased risk for stroke but have a reason to seek an alternative to blood thinning medications This clinical trial will compare the safety and efficacy of the Laminar Left Atrial Appendage Closure System to commercially available left atrial appendage closure devices
Participants in this trial will be randomly assigned one-to-one like flipping a coin for treatment with either the Laminar Left Atrial Appendage Closure System or a commercially available device WATCHMAN left atrial appendage closure device Amulet left atrial appendage occluder
Participants in this trial will be randomly assigned one-to-one like flipping a coin for treatment with either the Laminar Left Atrial Appendage Closure System or a commercially available device WATCHMAN left atrial appendage closure device Amulet left atrial appendage occluder
Detailed Description:
This prospective randomized controlled multicenter open-label pivotal clinical study will enroll participants with non-valvular atrial fibrillation who are eligible for short-term anticoagulation therapy but have a rationale to seek non-pharmacologic alternative Participants will be randomized 11 to the Laminar Left Atrial Appendage Closure System or commercially available device WATCHMAN left atrial appendage closure device Amulet left atrial appendage occluder The study will randomize 1500 eligible participants at up to 100 sites in the United States
After implantation of left atrial appendage closure device participants will be continued on appropriate medical therapy per guidelines or best local practices Participants will be followed for 5 years after device implantation
After implantation of left atrial appendage closure device participants will be continued on appropriate medical therapy per guidelines or best local practices Participants will be followed for 5 years after device implantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None