The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.
The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System. Subjects will be randomized in a 1:1 ratio to the Treatment Arm (Coherex WaveCrest LAA occlusion system) or the Control Arm (Boston Scientific's Watchman LAA occlusion system). The trial is designed to demonstrate that safety and effectiveness of the WaveCrest device are non-inferior to the Watchman device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
248
Percutaneous left atrial appendage closure
Percutaeous left atrial appendage closure
Grandview Medical Center
Percentage of Participants With Composite of All Cause Death, Procedure or Device Related Complications Requiring Percutaneous or Surgical Intervention or Major Bleeding
The primary safety outcome was the composite of death from any cause (all-cause mortality), procedure or device related complications requiring percutaneous or surgical intervention through 45 days post procedure or major bleeding throughout the duration of the trial. The analysis was based on sponsor assessment of adverse events data. Baseline was defined as 90 day prior to treatment or 90 days prior to randomization; baseline assessments could occur on the day of implant.
Time frame: All death, procedure- or device-related complications requiring percutaneous or surgical intervention: From baseline up to 45 days; major bleeding: From baseline up to 5 years 11 months
Percentage of Participants With Composite of Ischemic Stroke or Systemic Embolism at 24 Months
Percentage of participants with composite of ischemic stroke or systemic embolism at 24 months was reported.
Time frame: At 24 months
Percentage of Participants With Ischemic Stroke or Systemic Embolism With the WAVECREST Device in Comparison to the CHADS2 and CHA2DS2-VASc Imputed Risk of Ischemic Stroke or Systemic Embolism in the Absence of Anticoagulant Therapy
CHADS2 (congestive heart failure, hypertension, age \>=75 years (yrs), prior Stroke/transient ischemic attack (TIA)/Thromboembolism) and CHA2DS2-VASc scores (Vascular disease, Age 65- 74 yrs, female Sex) were developed to identify non-valvular atrial fibrillation (AF) participants at an elevated risk for ischemic stroke. CHADS2 score assign 1 point: congestive heart failure, hypertension, age \>= 75 yrs, diabetes mellitus; 2 points: prior stroke/TIA/thromboembolism. CHADS2 score ranges from 0 to 6. Higher scores indicated higher risk for ischemic strokes. CHA2DS2-VASc Score assign 1 point for each following risk factors: congestive heart failure, hypertension (blood pressure consistently above 140/90), diabetes mellitus, vascular disease, age 65 to74 yrs, female and assigned 2 points for age \>=75 yrs and prior stroke or TIA or thromboembolism each. Overall score ranged from 0 to a 9, with lower scores indicated lower risk and higher scores indicated higher risk for ischemic strokes.
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Birmingham, Alabama, United States
Dignity Health Mercy Gilbert Medical Center
Chandler, Arizona, United States
Pacific Heart Institute / St. John's Health Center
Los Angeles, California, United States
Medstar Heart and Vascular Institute - Washington Hospital Center
Washington D.C., District of Columbia, United States
St. Vincent's Medical Center
Jacksonville, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Wellstar Kennestone
Marietta, Georgia, United States
Baptist Health Lexington
Lexington, Kentucky, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, United States
Marquette General Hospital
Marquette, Michigan, United States
...and 15 more locations
Time frame: At 45 days
Percentage of Participants With Left Atrial Appendage (LAA) Closure
Percentage of participants with LAA closure, defined as a gap of \<= 5 millimetre (mm) at the 45-day visit as assessed by transesophageal echocardiogram (TEE) was reported.
Time frame: At 45 days