WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2

Phase 3

Terminated

Conditions: Stroke

Interventions: Device: Coherex WaveCrest® Left Atrial Appendage Occlusion System
Device: Watchman® LAA Closure Device

Registration Number: NCT03302494

Lead Sponsor: Coherex Medical

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 248

Inclusion Criteria

Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation
At least 18 years of age
Calculated CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3
Indication for warfarin therapy with an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulation
Willing and able to comply with post-implant anticoagulation and antiplatelet regimen
Willing to participate in the required follow-up visits and tests
Subject has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the IRB/EC at the site

Exclusion Criteria

Atrial fibrillation (AF) due to a reversible cause (e.g. thyrotoxicosis or postoperative)
Known contraindication and/or allergy to warfarin, nickel, aspirin, intravenous contrast or P2Y12 inhibitors (clopidogrel, ticagrelor, and prasugrel), which cannot be adequately pre-medicated or desensitized
Conditions other than AF requiring long-term anticoagulation therapy
Contraindications for percutaneous catheterization procedures
Prior surgical LAA occlusion/exclusion or implanted with LAA occlusion device, or any prior attempt of such procedures
Prior percutaneous or surgical closure of a patent foramen ovale or atrial septal defect
Inability or unwillingness to take oral anticoagulation for 45 days post-procedure
New York Heart Association (NYHA) Class IV heart failure
Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant
History of symptomatic carotid, intervertebral, or intracranial artery occlusion or stenosis without revascularization with the exception of known occlusion without symptoms > 6 months
Modified Rankin Scale (mRS) score ≥ 4
Chronic resting heart rate ≥ 110 bpm
Congenital cardiac anomalies requiring cardiac surgery or interventional repair
Stroke or transient ischemic attack (confirmed by Neurologist) within 60 days prior to enrollment
Myocardial infarction within 60 days prior to enrollment
Sepsis or any infection requiring oral antibiotic therapy within 14 days or intravenous antibiotic therapy within 30 days prior to enrollment
Surgical or interventional cardiovascular and non-cardiovascular procedure including cardioversion within 30 days prior to enrollment or AF ablation within 60 days prior to enrollment or any planned general surgery or interventional procedure within 90 days after enrollment or any planned cardiac surgery.
On renal replacement therapy, serum creatinine > 3.0 mg/dl (265 μmol/L) or calculated creatinine clearance < 25 ml/minute
Thrombocytopenia (<60,000 platelets/mm3), leucopenia (white blood cell count < 3,000 cells/mm³), or anemia (hemoglobin concentration < 10 grams/deciliter) based on blood work done within 30 days prior to enrollment
Any medical disorder or psychiatric illness that would interfere with successful completion of the trial
Currently participating in an investigational drug trial or another device trial that has not completed the primary endpoint (trials requiring extended follow-up for products that are commercially available are not considered investigational trials). Concurrent enrollment in the ACC LAAO Registry is permitted.
Subject belongs to a vulnerable population (see definition in Appendix I: Acronyms and Definitions)
Any condition that would reduce life expectancy to less than 2 years
Women of childbearing potential who are, or plan to become pregnant during the time of the trial (method of assessment per physician discretion)

Echocardiographic Exclusion Criteria

Left ventricular ejection fraction < 30%
Mitral valve stenosis defined as valve area < 1.5cm2, mean gradient > 6mmHg, or any valve deformity consistent with rheumatic valvular disease
Aortic valve stenosis defined as valve area ≤1.0cm2 or mean gradient >30mmHg
Circumferential pericardial effusion > 10mm or symptomatic pericardial effusion
Evidence of intracardiac thrombus
Cardiac tumor or myxoma
Atrial septal defect that warrants closure
Complex atheroma in the ascending aorta or aortic arch as evidenced by mobile plaque
Left Atrial Appendage size and shape are unsuitable for closure with a WaveCrest or Watchman device

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WaveCrest	Coherex WaveCrest® Left Atrial Appendage Occlusion System	WaveCrest left atrial appendage occluder
Watchman (control)	Watchman® LAA Closure Device	Watchman left atrial appendage closure device

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Composite of All Cause Death, Procedure or Device Related Complications Requiring Percutaneous or Surgical Intervention or Major Bleeding	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	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.
Percentage of Participants With Composite of Ischemic Stroke or Systemic Embolism at 24 Months	At 24 months	Percentage of participants with composite of ischemic stroke or systemic embolism at 24 months was reported.

Secondary Outcome Measures

Name	Time	Method
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	At 45 days	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.
Percentage of Participants With Left Atrial Appendage (LAA) Closure	At 45 days	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.

Trial Locations

Locations (25): Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
Dignity Health Mercy Gilbert Medical Center
🇺🇸
Chandler, Arizona, United States
Medstar Heart and Vascular Institute - Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
St. Vincent's Medical Center
🇺🇸
Jacksonville, Florida, United States
Baptist Health Lexington
🇺🇸
Lexington, Kentucky, United States
Marquette General Hospital
🇺🇸
Marquette, Michigan, United States
Northwell Health
🇺🇸
Bay Shore, New York, United States
New York University- NYU Langone Cardiac
🇺🇸
New York, New York, United States
New York University
🇺🇸
New York, New York, United States
UPMC Pinnacle Health Cardiovascular Institute
🇺🇸
Harrisburg, Pennsylvania, United States
Baylor Scott & White All Saints Medical Center
🇺🇸
Fort Worth, Texas, United States
Heart Hospital Baylor Plano (Baylor Research Institute)
🇺🇸
Plano, Texas, United States
Christus Trinity Clinic Research
🇺🇸
Tyler, Texas, United States
Monash Health
🇦🇺
Melbourne, Australia
St. Vincent's Hospital
🇦🇺
Sydney, Australia
Grandview Medical Center
🇺🇸
Birmingham, Alabama, United States
Pacific Heart Institute / St. John's Health Center
🇺🇸
Los Angeles, California, United States
Piedmont Heart Institute
🇺🇸
Atlanta, Georgia, United States
Wellstar Kennestone
🇺🇸
Marietta, Georgia, United States
MedStar Union Memorial Hospital
🇺🇸
Baltimore, Maryland, United States
Munson Medical Center
🇺🇸
Traverse City, Michigan, United States
Cardiology Associates Research, LLC
🇺🇸
Tupelo, Mississippi, United States
Ohio State University
🇺🇸
Columbus, Ohio, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸
Austin, Texas, United States
Virginia Commonwealth University
🇺🇸
Richmond, Virginia, United States