CORRAL-AF: Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF Valvular AF

Sponsor

Brian O'Neill (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04684212

Collaborator

Lifetech Scientific (Shenzhen) Co., Ltd. (Industry)

Enrollment

Location

Arm

132

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective is to demonstrate the safety and efficacy of the implantation of the LAmbreTM device in patients with large or irregularly shaped appendages with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Left Atrial Appendage Thrombosis CVA	Device: LAmbreTM Left Atrial Appendage Closure System	N/A

Detailed Description

This prospective, single center, pilot study will enroll a total of 15 patients. Patients presenting with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHA2DS2-VASc scores, and who are recommended for oral anticoagulation therapy but have an appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, and who meet all eligibility criteria will be enrolled in the study.

Subjects will have clinical follow-up in-hospital and at 45 days, 6 months, 12 months, and 2, 3, 4, and 5 years. Transesophageal echocardiographic (TEE) or CT follow-up will occur at 45 days.

The LAmbreTM Left Atrial Appendage (LAA) Closure System is intended to reduce the risk of thromboembolism from the left atrial appendage (LAA) in patients with nonvalvular atrial fibrillation who:

Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for oral anticoagulation (OAC) therapy; AND
Are deemed by their physician to be suitable for OAC; AND
Have an appropriate rationale to seek a non-pharmacological alternative to OAC, taking into account the safety and effectiveness of the device compared to OAC

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This prospective, single center, pilot study will enroll a total of 15 patients.This prospective, single center, pilot study will enroll a total of 15 patients.

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF (CORRAL-AF) IDE Registry Trial

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2028

Anticipated Study Completion Date :

Apr 1, 2033

Arms and Interventions

Arm	Intervention/Treatment
Other: LAmbreTM Left Atrial Appendage Closure System single center, pilot study will enroll a total of 15 patients	Device: LAmbreTM Left Atrial Appendage Closure System The LAmbre device is a self-expanding occluder, composed of a distal Umbrella and a proximal Cover laser welded together, delivered percutaneously via femoral venous access and trans-septal puncture. The distal Umbrella consists of an elastic nitinol frame and outer PET membrane, and has circumferential anchors to secure the occluder to the left atrial appendage (LAA) wall. The proximal Cover is a disc of elastic nitinol mesh, which seals the orifice of the LAA and minimizes thrombus formation, and includes a PET membrane to prevent the passage of blood into the LAA after implantation. Other Names: LAmbre device

Arm

Intervention/Treatment

Other: LAmbreTM Left Atrial Appendage Closure System

single center, pilot study will enroll a total of 15 patients

Device: LAmbreTM Left Atrial Appendage Closure System

The LAmbre device is a self-expanding occluder, composed of a distal Umbrella and a proximal Cover laser welded together, delivered percutaneously via femoral venous access and trans-septal puncture. The distal Umbrella consists of an elastic nitinol frame and outer PET membrane, and has circumferential anchors to secure the occluder to the left atrial appendage (LAA) wall. The proximal Cover is a disc of elastic nitinol mesh, which seals the orifice of the LAA and minimizes thrombus formation, and includes a PET membrane to prevent the passage of blood into the LAA after implantation.

Other Names:

LAmbre device

Outcome Measures

Primary Outcome Measures

Overall safety, assessed at 12 months [12 months]
Major procedure-related complications, defined as the composite of cardiac perforation, pericardial effusion with tamponade, device embolization, and major vascular complications AND major adverse events, defined as all death, all stroke and major bleeding
Overall efficacy [12 months]
Overall efficacy, defined as the composite of cardiovascular death, ischemic stroke, and systemic embolization, evaluated throughout the time on study and Efficacy will be assessed when all subjects have reached at least the 12-month follow-up time point (assuming a 24-month enrollment period)

Secondary Outcome Measures

Appendage Closure Success [45 days]
Closure success, defined as technical success followed by successful LAA closure (complete LAA closure or peri-device residual jet <4 mm in width by TEE or CT

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 in a shared decision model with a non-implanting physician
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 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 may accommodate implantation of the WATCHMAN device.
LVEF <30%
Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE within 2 days prior to implant
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)
Presence of a cardiac tumor