Clinical trial NCT03302494: WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2
Official title: WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2. A Prospective, Multicenter, Randomized, Active Controlled, Clinical Trial of the Coherex WaveCrest® Left Atrial Appendage Occlusion System Compared to the Watchman® LAA Closure Device for the Reduction in Risk of Ischemic Stroke or Systemic Embolism in Subjects With Non-valvular Atrial Fibrillation That Have an Appropriate Rationale to Seek a Non-pharmacologic Alternative to Chronic Oral Anticoagulation.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Stroke
Keywords: Non-valvular Atrial Fibrillation
Left Atrial Appendage
Lead sponsor: Coherex Medical
Sponsor class: INDUSTRY
Collaborators: name: Biosense Webster, Inc.
First posted: 2017-10-05
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation
2. At least 18 years of age
3. Calculated CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3
4. Indication for warfarin therapy with an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulation
5. Willing and able to comply with post-implant anticoagulation and antiplatelet regimen
6. Willing to participate in the required follow-up visits and tests
7. 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:

1. Atrial fibrillation (AF) due to a reversible cause (e.g. thyrotoxicosis or postoperative)
2. 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
3. Conditions other than AF requiring long-term anticoagulation therapy
4. Contraindications for percutaneous catheterization procedures
5. Prior surgical LAA occlusion/exclusion or implanted with LAA occlusion device, or any prior attempt of such procedures
6. Prior percutaneous or surgical closure of a patent foramen ovale or atrial septal defect
7. Inability or unwillingness to take oral anticoagulation for 45 days post-procedure
8. New York Heart Association (NYHA) Class IV heart failure
9. Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant
10. History of symptomatic carotid, intervertebral, or intracranial artery occlusion or stenosis without revascularization with the exception of known occlusion without symptoms \> 6 months
11. Modified Rankin Scale (mRS) score ≥ 4
12. Chronic resting heart rate ≥ 110 bpm
13. Congenital cardiac anomalies requiring cardiac surgery or interventional repair
14. Stroke or transient ischemic attack (confirmed by Neurologist) within 60 days prior to enrollment
15. Myocardial infarction within 60 days prior to enrollment
16. Sepsis or any infection requiring oral antibiotic therapy within 14 days or intravenous antibiotic therapy within 30 days prior to enrollment
17. 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.
18. On renal replacement therapy, serum creatinine \> 3.0 mg/dl (265 μmol/L) or calculated creatinine clearance \< 25 ml/minute
19. 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
20. Any medical disorder or psychiatric illness that would interfere with successful completion of the trial
21. 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.
22. Subject belongs to a vulnerable population (see definition in Appendix I: Acronyms and Definitions)
23. Any condition that would reduce life expectancy to less than 2 years
24. 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

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

Primary outcomes:
measure: Percentage of Participants With Composite of All Cause Death, Procedure or Device Related Complications Requiring Percutaneous or Surgical Intervention or Major Bleeding
timeFrame: 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
measure: Percentage of Participants With Composite of Ischemic Stroke or Systemic Embolism at 24 Months
timeFrame: At 24 months
Secondary outcomes:
measure: 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
timeFrame: At 45 days
measure: Percentage of Participants With Left Atrial Appendage (LAA) Closure
timeFrame: At 45 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Chandler
country: United States
facility: Dignity Health Mercy Gilbert Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Pacific Heart Institute / St. John's Health Center
state: California
city: Washington
country: United States
facility: Medstar Heart and Vascular Institute - Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: St. Vincent's Medical Center
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Marietta
country: United States
facility: Wellstar Kennestone
state: Georgia
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: Marquette
country: United States
facility: Marquette General Hospital
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Tupelo
country: United States
facility: Cardiology Associates Research, LLC
state: Mississippi
city: Bay Shore
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: New York University- NYU Langone Cardiac
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Harrisburg
country: United States
facility: UPMC Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Fort Worth
country: United States
facility: Baylor Scott & White All Saints Medical Center
state: Texas
city: Plano
country: United States
facility: Heart Hospital Baylor Plano (Baylor Research Institute)
state: Texas
city: Tyler
country: United States
facility: Christus Trinity Clinic Research
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Melbourne
country: Australia
facility: Monash Health
city: Sydney
country: Australia
facility: St. Vincent's Hospital
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Vivek Reddy, MD
role: STUDY_CHAIR
affiliation: MOUNT SINAI HOSPITAL
name: Gregg Stone, MD
role: STUDY_CHAIR
References: