WAVECREST Post Market Clinical Follow-Up (PMCF) Study

Study Overview
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Brief Summary
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The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System in the current medical practice setting in patients with non-valvular atrial fibrillation who are at increased risk for stroke. Up to 65 subjects may be enrolled at up to 15 study sites in Europe. Patients will be followed through 45 days post-procedure.

Detailed Description
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The Coherex WaveCrest® Left Atrial Appendage Occlusion System is designed to permanently occlude the Left Atrial Appendage (LAA).

Official Title
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A Prospective, Multicenter, Non-randomized, Post-market Clinical Follow-up Study to Confirm Safety and Performance of the Coherex WaveCrest® Left Atrial Appendage Occlusion System in Patients With Non-valvular Atrial Fibrillation

Conditions
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Non-valvular Atrial Fibrillation

Intervention / Treatment
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* Device: Percutaneous LAA Closure
* Drug: Anticoagulation or Clopidogrel


Participation Criteria
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Eligibility Criteria
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The criteria for implant are in accordance to the current version of the Instructions for Use: Inclusion Criteria: Non-valvular paroxysmal, persistent, or permanent atrial fibrillation 18 years of age or older LAA anatomy amenable to treatment by percutaneous techniques Risk factors for potential thrombus formation in the LAA Willing to participate in the required follow-up visits and tests Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee or Institutional Review Board at the study site Exclusion Criteria: Known contraindication to percutaneous transseptal intervention Left atrial appendage anatomy or size that will not allow appropriate implantation of the WaveCrest Implant Intracardiac thrombus or other cardiac abnormality visualized prior to implant that would significantly impact procedural safety Mitral valve stenosis < 1.5 cm2 or any stenosis consistent with rheumatic valvular disease or history of mitral valve replacement or repair Known contraindication and/or allergy to nickel Known active bacterial infection (i.e., sepsis, endocarditis) Any known medical condition or overall health of the subject that could adversely affect procedural safety or potentially prevent the patient from completing all study required visits and tests. Pregnant or breastfeeding women due to the risk of exposure to x-rays and medications associated with the implant procedure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WaveCrest®<br>Implant of WaveCrest® Left Atrial Appendage Occlusion System | Device: Percutaneous LAA Closure<br>* LAA Closure with the WaveCrest LAA Occlusion System (study device)<br>Drug: Anticoagulation or Clopidogrel<br>* Subjects either continue on anticoagulation or receive clopidogrel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all-cause deaths and device and/or procedure related events while using the WaveCrest device | Composite rate consists of: All-cause mortality Pericardial effusion requiring intervention Device embolization from the Left Atrial Appendage (LAA) Device thrombus Ischemic stroke | 45 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful device release within LAA | Position confirmed by imaging | Intraoperative | 
| Technical Success at implant | Occlusion of the LAA No device-related complications No leak >5mm on color Doppler Transesophageal Echocardiography (TEE) | Intraoperative | 
| Procedural Success | Technical success No procedure-related complications except uncomplicated (minor) device embolization (resolved by percutaneous retrieval during the procedure without surgical intervention or damage to surrounding cardiovascular structures) | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-valvular atrial fibrillation, Atrial Fibrillation, Stroke, Left Atrial Appendage (LAA), LAA Closure, LAA Occlusion, WaveCrest