Assessing the Safety and Efficacy of the LAmbre™ Plus Device
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT06465706
- Lead Sponsor
- Kansas City Heart Rhythm Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - The patient is a male or non-pregnant female =18 years of age<br><br> - The patient has documented paroxysmal, persistent, or permanent non- valvular atrial<br> fibrillation<br><br> - The patient has a CHADS2 score = 2 or a CHA2DS2-VASc score of = 3, and is<br> recommended for oral anticoagulation therapy<br><br> - The patient is deemed by their physician to be suitable for short-term warfarin<br> therapy, but there is an appropriate rationale for seeking a non-pharmacologic<br> alternative to oral anticoagulation<br><br> - The patient is deemed suitable for LAA closure by a multidisciplinary heart team,<br> including at least 1 investigator (e.g. cardiologists) and 1 clinician not involved<br> as part of the procedure team using a shared decision making process, and this<br> determination has been documented in the patient's medical record<br><br> - The patient is willing and able to comply with protocol-specified treatment and<br> follow-up evaluations<br><br> - The patient (or his or her legally authorized representative) has been informed of<br> the nature of the study, agrees to its provisions, and has been provided written<br> informed consent approved by the appropriate Institutional Review Board (IRB) or<br> Ethics Committee (EC)<br><br>Exclusion Criteria:<br><br> - Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year<br> following index procedure. Female patients of childbearing potential must have a<br> negative pregnancy test done within 7 days prior to index procedure per site<br> standard test.<br><br> - Patients with atrial fibrillation that is defined by a single occurrence, or that is<br> transient or reversible (e.g., secondary to CABG, an interventional procedure,<br> pneumonia, or hyperthyroidism)<br><br> - Patients who require long-term anticoagulation for a condition other than atrial<br> fibrillation<br><br> - Patients with an indication for chronic P2Y12 platelet inhibition therapy<br><br> - Patients not suitable for short term warfarin (including due to bleeding diathesis<br> or coagulopathy or absolute contraindication warfarin) or who will refuse<br> transfusion<br><br> - Patients with rheumatic mitral valve disease, known severe aortic stenosis requiring<br> surgical or percutaneous valve replacement, or existing mechanical valve prosthesis<br><br> - Active infection with bacteremia<br><br> - Known hypersensitivity or contraindication to aspirin, clopidogrel,<br> heparin/bivalirudin, any device material or component (nitinol, nickel, titanium,<br> PET), and/or contrast sensitivity that cannot be adequately pre-medicated<br><br> - Anatomic conditions that would prevent performance of the LAA occlusion procedure<br> (e.g., prior atrial septal defect [ASD] or patient foramen ovale [PFO] surgical<br> repair or implanted closure device, or obliterated left atrial appendage)<br><br> - Recent (within 30 days pre-procedure) or planned (within 60 days post- procedure)<br> cardiac or non-cardiac interventional or surgical procedure (e.g., cardioversion,<br> ablation, percutaneous coronary intervention, cataract surgery, etc.)<br><br> - Recent (within 90 days pre-procedure) stroke, transient ischemic attack, or<br> myocardial infarction<br><br> - Severe heart failure (New York Heart Association Class IV)<br><br> - Known asymptomatic carotid artery disease with>70% diameter stenosis OR symptomatic<br> carotid disease (>50% diameter stenosis with ipsilateral stroke or TIA). Subjects<br> with prior carotid endarterectomy or carotid stent placement may be enrolled,<br> provided that known diameter stenosis is <50%.<br><br> - Past or pending heart or any other organ transplant, or on the waiting list for any<br> organ transplant<br><br> - Known other medical illness or known history of substance abuse that may cause<br> non-compliance with the protocol, confound data interpretation, or is associated<br> with a life expectancy of less than 2 years<br><br> - Current participation in another investigational drug or device study<br> Echocardiographic Exclusion Criteria<br><br> - Left atrial appendage anatomy cannot accommodate either the LAmbre Plus LAAO device<br> or the Control device per manufacturer IFU (e.g., the anatomy and sizing must be for<br> both device to be enrolled in the trial or maximum LAAO length < maximum ostium<br> width by TEE)<br><br> - LVEF <30%<br><br> - Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE<br> within 2 days prior to implant<br><br> - Moderate or large circumferential pericardial effusion >10 mm or symptomatic<br> pericardial effusion, signs or symptoms of acute or chronic pericarditis, or<br> evidence of tamponade physiology. In the event of a treatable pericardial effusion,<br> the subject may undergo implantation at a later time after it is adequately treated.<br><br> - Atrial septal defect that warrants closure.<br><br> - Presence of a high risk patent foramen ovale (PFO), defined as an atrial septal<br> aneurysm (excursion >15 mm or length >15 mm) or large shunt (early, within 3 beats<br> and/or substantial passage of bubbles)<br><br> - Moderate or severe mitral valve stenosis (mitral valve area <1.5 cm2)<br><br> - Complex atheroma with mobile plaque of the descending aorta and/or aortic arch<br> (Grade 4 or higher)<br><br> - Evidence of a Cardiac Tumor
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major procedure related complications - cardiac perforation;Major procedure related complications - pericardial effusion with tamponade or requiring drainage;Major procedure related complications - device embolization;Major adverse event - Death;Major adverse event - all strokes;Major adverse event - systemic embolization;Major adverse event - major bleeding
- Secondary Outcome Measures
Name Time Method vascular complications;Major adverse event;mortality;myocardial infarction;periprocedural stroke;bleeding complications;major procedure-related complications