An interventional study of LAmbre investigational device in Atrial Fibrillation, sponsored by Kansas City Heart Rhythm Research Foundation. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by Kansas City Heart Rhythm Research Foundation · Not applicable, Interventional, and Treatment
Randomized controlled trial assessing the safety and efficacy of the LAmbre Plus LAA Closure System to rescue the risk of thromboembolism in patients with non-valvular AF.
The goal of this clinical trial is to demonstrate the safety and efficacy of the LAmbre Plus device in patients with non-valvular atrial fibrillation in comparison with the commercially available transcatheter LAAO device(s). The main questions it aims to answer are:
Overall safety of the device that is assessed at the 12 month time period. Overall efficacy, after all subjects have reached the 18 month time period.
Participants will be randomized to either the LAmbre device or other FDA approved LAAO devices.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 1,826 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Kansas City Heart Rhythm Research Foundation is the lead sponsor of 28 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
LAmbre Plus LAAO is a second-generation device intended for investigational use only in the United States.
Device: LAmbre investigational device
The control devices for the study will be commercially available transcatheter LAAO devices. Currently, there are three FDA approved devices (WATCHMAN FLX and WATCHMAN FLX Pro from Boston Scientific and Amplatzer Amulet from Abbott Laboratories) all of which can be used in subjects assigned to the control group.
Device: LAmbre investigational device
Randomized 1:1 to either experimental group or control group.
Major procedure related complications - cardiac perforation
Cardiac perforation can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE.
Time frame: up to 7 days following implant procedure
Major procedure related complications - pericardial effusion with tamponade or requiring drainage
Common complications can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE.
Time frame: up to 7 days following implant procedure
Major procedure related complications - device embolization
Procedure complications can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE.
Time frame: up to 7 days following implant procedure
Major adverse event - Death
Death is observed by lack of oxygen, lack of pulse, succession of neurological activity.
Time frame: up to 7 days following implant procedure
Major adverse event - all strokes
Stroke is identified by neurologic imaging and transient or permanent motor or sensory deficient.
Time frame: up to 7 days following implant procedure
Major adverse event - systemic embolization
Systemic embolization assessed by onsite symptoms and confirmed by diagnostic imaging.
Time frame: up to 7 days following implant procedure
Major adverse event - major bleeding
Visual bleeding or a drop in hemoglobin of 2 units and requiring transfusion.
Time frame: up to 7 days following implant procedure
Major adverse event
composite of cardiovascular death, overs CNS injury and major bleeding
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
mortality
cardiovascular or non-cardiovascular and reported cumulatively and individually
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
myocardial infarction
Defined as ST or nonST ECG changes with positive cardiac bio markers.
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
periprocedural stroke
Motor and sensory deficits observed and imaging confirmed.
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
bleeding complications
Visual bleeding or a drop in hemoglobin
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
major procedure-related complications
vascular or cardiac complications occurring due to the procedure.
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
vascular complications
vascular complications are hematomas, aneurysms, and ischemic limb.
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kansas City Heart Rhythm Research Foundation