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

• ClinicalTrials.gov Identifier: NCT03302494
• Recruitment Status: Active, not recruiting
• First Posted: October 5, 2017
• Last Update Posted: August 11, 2020
• Sponsor: Coherex Medical
• Collaborator: Biosense Webster, Inc.
• Information provided by (Responsible Party): Coherex Medical

Tracking Information

• First Submitted Date: September 29, 2017
• First Posted Date: October 5, 2017
• Last Update Posted Date: August 11, 2020
• Actual Study Start Date: December 27, 2017
• Estimated Primary Completion Date: January 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 4, 2017)

• Procedure or device related complications [ Time Frame: 45 Days ]
  Part of the composite rate of the primary safety endpoint.
• All Death [ Time Frame: 24 months ]
  Part of the composite rate of the primary safety endpoint.
• Major Bleeding [ Time Frame: 24 months ]
  Part of the composite rate of the primary safety endpoint.
• Ischemic stroke, systemic embolism [ Time Frame: 24 months ]
  The primary effectiveness endpoint is a composite rate of ischemic stroke or systemic embolism at 24 months

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 4, 2017)

Ischemic stroke, systemic embolism [ Time Frame: 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

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

• Condition: Stroke

Intervention

• Device: Coherex WaveCrest® Left Atrial Appendage Occlusion System
  Percutaneous left atrial appendage closure
• Device: Watchman® LAA Closure Device
  Percutaeous left atrial appendage closure

Study Arms

• Experimental: WaveCrest
  WaveCrest left atrial appendage occluder
  Intervention: Device: Coherex WaveCrest® Left Atrial Appendage Occlusion System
• Active Comparator: Watchman (control)
  Watchman left atrial appendage closure device
  Intervention: Device: Watchman® LAA Closure Device

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: October 4, 2017): 1250
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2028
• Estimated Primary Completion Date: January 1, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, United States

Administrative Information

• NCT Number: NCT03302494
• Other Study ID Numbers: CHX_IP014
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Coherex Medical
• Study Sponsor: Coherex Medical
• Collaborators: Biosense Webster, Inc.

Investigators

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

• PRS Account: Coherex Medical
• Verification Date: August 2020