Assessing the Safety and Efficacy of the LAmbre™ Plus Device

NCT06465706 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: LA-US-01
• Study Type: interventional
• Target: 1,826
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

Left Atrial Appendage Occlusion; Stroke Risk

Outcome Measures

Primary Outcomes (7)

• Major procedure related complications - cardiac perforation

  Cardiac perforation can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE.

  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.

  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.

  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.

  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.

  up to 7 days following implant procedure

• Major adverse event - systemic embolization

  Systemic embolization assessed by onsite symptoms and confirmed by diagnostic imaging.

  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.

  up to 7 days following implant procedure

Secondary Outcomes (7)

• Major adverse event

  45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years

• mortality

  45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years

• myocardial infarction

  45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years

• periprocedural stroke

  45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years

• bleeding complications

  45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years

Study Arms (2)

LAmbre Device

EXPERIMENTAL

LAmbre Plus LAAO is a second-generation device intended for investigational use only in the United States.

Device: LAmbre investigational device

FDA approved LAAO devices

ACTIVE COMPARATOR

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

Interventions

LAmbre investigational device DEVICE

Randomized 1:1 to either experimental group or control group.

FDA approved LAAO devices; LAmbre Device

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is a male or non-pregnant female ≥18 years of age
• The patient has documented paroxysmal, persistent, or permanent non- valvular atrial fibrillation
• The patient has a CHADS2 score ≥ 2 or a CHA2DS2-VASc score of ≥ 3, and is recommended for oral anticoagulation therapy
• The patient is deemed by their physician to be suitable for short-term warfarin therapy, but there is an appropriate rationale for seeking a non-pharmacologic alternative to oral anticoagulation
• The patient is deemed suitable for LAA closure by a multidisciplinary heart team, including at least 1 investigator (e.g. cardiologists) and 1 clinician not involved as part of the procedure team using a shared decision making process, and this determination has been documented in the patient's medical record
• The patient is willing and able to comply with protocol-specified treatment and follow-up evaluations
• The patient (or his or her legally authorized representative) has been informed of the nature of the study, agrees to its provisions, and has been provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)

You may not qualify if:

• Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to index procedure per site standard test.
• Patients with atrial fibrillation that is defined by a single occurrence, or that is transient or reversible (e.g., secondary to CABG, an interventional procedure, pneumonia, or hyperthyroidism)
• Patients who require long-term anticoagulation for a condition other than atrial fibrillation
• Patients with an indication for chronic P2Y12 platelet inhibition therapy
• Patients not suitable for short term warfarin (including due to bleeding diathesis or coagulopathy or absolute contraindication warfarin) or who will refuse transfusion
• Patients with rheumatic mitral valve disease, known severe aortic stenosis requiring surgical or percutaneous valve replacement, or existing mechanical valve prosthesis
• Active infection with bacteremia
• Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin/bivalirudin, any device material or component (nitinol, nickel, titanium, PET), and/or contrast sensitivity that cannot be adequately pre-medicated
• Anatomic conditions that would prevent performance of the LAA occlusion procedure (e.g., prior atrial septal defect \[ASD\] or patient foramen ovale \[PFO\] surgical repair or implanted closure device, or obliterated left atrial appendage)
• Recent (within 30 days pre-procedure) or planned (within 60 days post- procedure) cardiac or non-cardiac interventional or surgical procedure (e.g., cardioversion, ablation, percutaneous coronary intervention, cataract surgery, etc.)
• Recent (within 90 days pre-procedure) stroke, transient ischemic attack, or myocardial infarction
• Severe heart failure (New York Heart Association Class IV)
• Known asymptomatic carotid artery disease with\>70% diameter stenosis OR symptomatic carotid disease (\>50% diameter stenosis with ipsilateral stroke or TIA). Subjects with prior carotid endarterectomy or carotid stent placement may be enrolled, provided that known diameter stenosis is \<50%.
• Past or pending heart or any other organ transplant, or on the waiting list for any organ transplant
• Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol, confound data interpretation, or is associated with a life expectancy of less than 2 years

Sponsors & Collaborators

• Kansas City Heart Rhythm Research Foundation: lead

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MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dhanunjaya Lakkireddy, MD

  KCCARF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins, RN, BSN

CONTACT

816-651-1969; datkins@kchrf.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients and family will be blinded to which device they received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 20, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): January 31, 2030
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share