Assessing the Safety and Efficacy of the LAmbre™ Plus Device (REDUCE-AF)

August 21, 2024 updated by: Kansas City Heart Rhythm Research Foundation

A Prospective, Multicenter, Randomized Controlled Trial Assessing the Safety and Efficacy of the LAmbre™ Plus Left Atrial Appendage Closure System to REDUCE the Risk of Thromboembolism in Patients With Non-Valvular Atrial Fibrillation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

1826

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • Current participation in another investigational drug or device study Echocardiographic Exclusion Criteria
  • Left atrial appendage anatomy cannot accommodate either the LAmbre Plus LAAO device or the Control device per manufacturer IFU (e.g., the anatomy and sizing must be for both device to be enrolled in the trial or maximum LAAO length < maximum ostium width by TEE)
  • LVEF <30%
  • Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE within 2 days prior to implant
  • Moderate or large circumferential pericardial effusion >10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology. In the event of a treatable pericardial effusion, the subject may undergo implantation at a later time after it is adequately treated.
  • Atrial septal defect that warrants closure.
  • Presence of a high risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (excursion >15 mm or length >15 mm) or large shunt (early, within 3 beats and/or substantial passage of bubbles)
  • Moderate or severe mitral valve stenosis (mitral valve area <1.5 cm2)
  • Complex atheroma with mobile plaque of the descending aorta and/or aortic arch (Grade 4 or higher)
  • Evidence of a Cardiac Tumor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LAmbre Device
LAmbre Plus LAAO is a second-generation device intended for investigational use only in the United States.
Device: LAmbre investigational device
Randomized 1:1 to either experimental group or control group.
Active Comparator: FDA approved LAAO devices
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major procedure related complications - cardiac perforation
Time Frame: up to 7 days following implant procedure
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
Time Frame: up to 7 days following implant procedure
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
Time Frame: up to 7 days following implant procedure
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
Time Frame: up to 7 days following implant procedure
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
Time Frame: up to 7 days following implant procedure
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
Time Frame: up to 7 days following implant procedure
Systemic embolization assessed by onsite symptoms and confirmed by diagnostic imaging.
up to 7 days following implant procedure
Major adverse event - major bleeding
Time Frame: up to 7 days following implant procedure
Visual bleeding or a drop in hemoglobin of 2 units and requiring transfusion.
up to 7 days following implant procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse event
Time Frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
composite of cardiovascular death, overs CNS injury and major bleeding
45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
mortality
Time Frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
cardiovascular or non-cardiovascular and reported cumulatively and individually
45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
myocardial infarction
Time Frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
Defined as ST or nonST ECG changes with positive cardiac bio markers.
45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
periprocedural stroke
Time Frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
Motor and sensory deficits observed and imaging confirmed.
45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
bleeding complications
Time Frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
Visual bleeding or a drop in hemoglobin
45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
major procedure-related complications
Time Frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
vascular or cardiac complications occurring due to the procedure.
45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
vascular complications
Time Frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
vascular complications are hematomas, aneurysms, and ischemic limb.
45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas City Heart Rhythm Research Foundation

Investigators

  • Principal Investigator: Dhanunjaya Lakkireddy, MD, KCCARF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

January 31, 2030

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LA-US-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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