Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE)

Study Overview
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Brief Summary
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This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2 stroke risk stratification score of 1 or greater. This is a prospective, non-randomized study to evaluate the initial use of the next generation WATCHMAN Device.

Official Title
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Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: WATCHMAN LAA Closure Technology (Gen 4.0)


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Paroxysmal, persistent, or permanent non-valvular atrial fibrillation Eligible for long-term Warfarin therapy; Eligible to come off Warfarin therapy if the LAA is sealed Calculated CHADS2 score of 1 or greater Key Exclusion Criteria: New York Heart Association Class IV Congestive Heart Failure Recent MI (within 3 months) ASD and/or atrial septal repair or closure device Resting heart rate >110 bpm Has an implanted mechanical valve prosthesis Left atrial appendage is obliterated Has undergone heart transplantation Has symptomatic carotid disease Contraindicated for aspirin LVEF < 30% Cardiac Tumor

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implantable device<br>WATCHMAN LAA Closure Technology (Gen 4.0) | Device: WATCHMAN LAA Closure Technology (Gen 4.0)<br>* Implantation of the WATCHMAN device into the left atrial appendage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful implantation of the next generation WATCHMAN device without the occurance of life-threatening events caused by the device and/or procedure. | The implantation of the next generation WATCHMAN device without the occurrence of life-threatening events caused by the device and/or the procedure. These events may include device embolization requiring retrieval, bleeding events such as pericardial effusion requiring drainage, cardiac perforation requiring operation, cranial bleeding events due to any source, and any systemic embolic events related to the device or procedure. | 12-Months | 
| Device Success | Device success, defined as successful delivery and release of the WATCHMAN implant into the LAA, including successful re-capture and retrieval if necessary. | Implant through 45-Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Stroke, Warfarin, Coumadin, TIA, Trans Ischemic Attack