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WAVECREST2: WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2

Sponsor
Coherex Medical (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03302494
Collaborator
Biosense Webster, Inc. (Industry)
1,550
Enrollment
25
Locations
2
Arms
143.1
Anticipated Duration (Months)
62
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Coherex WaveCrest® Left Atrial Appendage Occlusion System
  • Device: Watchman® LAA Closure Device
 Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1550 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
If the subject is suspected of having a stroke since their most recent follow-up, a Neurologist blinded to subject's randomization and implanted device must evaluate the subject or otherwise provide rationale for why an in-person neurology visit and exam are unnecessary. Neurology or blinded trial personnel should also administer mRS & NIHSS if there is suspicion of stroke A Clinical Events Committee, also blinded to subject's randomization, will adjudicate primary safety and effectiveness.
Primary Purpose:
Prevention
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.
Actual Study Start Date :
Dec 27, 2017
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Dec 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: WaveCrest

WaveCrest left atrial appendage occluder

Device: Coherex WaveCrest® Left Atrial Appendage Occlusion System
Percutaneous left atrial appendage closure
Active Comparator: Watchman (control)

Watchman left atrial appendage closure device

Device: Watchman® LAA Closure Device
Percutaeous left atrial appendage closure

Outcome Measures

Primary Outcome Measures

  1. Procedure or device related complications [45 Days]

    Part of the composite rate of the primary safety endpoint.

  2. All Death [24 months]

    Part of the composite rate of the primary safety endpoint.

  3. Major Bleeding [24 months]

    Part of the composite rate of the primary safety endpoint.

  4. Ischemic stroke, systemic embolism [24 months]

    The primary effectiveness endpoint is a composite rate of ischemic stroke or systemic embolism at 24 months

Secondary Outcome Measures

  1. Ischemic stroke, systemic embolism [45 days]

    The secondary endpoint is the rate of 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Grandview Medical Center Birmingham Alabama United States 35243
2 Dignity Health Mercy Gilbert Medical Center Chandler Arizona United States 85224
3 Pacific Heart Institute / St. John's Health Center Los Angeles California United States 90033
4 Medstar Heart and Vascular Institute - Washington Hospital Center Washington District of Columbia United States 20010
5 St. Vincent's Medical Center Jacksonville Florida United States 32204
6 Piedmont Heart Institute Atlanta Georgia United States 30309
7 Wellstar Kennestone Marietta Georgia United States 30060
8 Baptist Health Lexington Lexington Kentucky United States 40503
9 MedStar Union Memorial Hospital Baltimore Maryland United States 21218
10 Marquette General Hospital Marquette Michigan United States 49855
11 Munson Medical Center Traverse City Michigan United States 49684
12 Cardiology Associates Research, LLC Tupelo Mississippi United States 38801
13 Northwell Health Bay Shore New York United States 11706
14 New York University- NYU Langone Cardiac New York New York United States 10016
15 New York University New York New York United States 10016
16 Icahn School of Medicine at Mount Sinai New York New York United States 10029
17 Ohio State University Columbus Ohio United States 43210
18 UPMC Pinnacle Health Cardiovascular Institute Harrisburg Pennsylvania United States 17104
19 Texas Cardiac Arrhythmia Research Foundation Austin Texas United States 78705
20 Baylor Scott & White All Saints Medical Center Fort Worth Texas United States 76104
21 Heart Hospital Baylor Plano (Baylor Research Institute) Plano Texas United States 75093
22 Christus Trinity Clinic Research Tyler Texas United States 75702
23 Virginia Commonwealth University Richmond Virginia United States 23298
24 Monash Health Melbourne Australia
25 St. Vincent's Hospital Sydney Australia 2023

Sponsors and Collaborators

  • Coherex Medical
  • Biosense Webster, Inc.

Investigators

  • Study Chair: Vivek Reddy, MD, MOUNT SINAI HOSPITAL
  • Study Chair: Gregg Stone, MD, MOUNT SINAI HOSPITAL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coherex Medical
ClinicalTrials.gov Identifier:
NCT03302494
Other Study ID Numbers:
  • CHX_IP014
First Posted:
Oct 5, 2017
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Coherex Medical
Non-valvular Atrial Fibrillation
Left Atrial Appendage
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Aug 9, 2022