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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03302494
Registration number
NCT03302494
Ethics application status
Date submitted
29/09/2017
Date registered
5/10/2017
Date last updated
20/03/2024
Titles & IDs
Public title
WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2
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Scientific 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.
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Secondary ID [1]
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CHX_IP014
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Universal Trial Number (UTN)
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Trial acronym
WAVECREST2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stroke
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Condition category
Condition code
Stroke
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Haemorrhagic
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Stroke
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Coherex WaveCrest® Left Atrial Appendage Occlusion System
Treatment: Devices - Watchman® LAA Closure Device
Experimental: WaveCrest - WaveCrest left atrial appendage occluder
Active Comparator: Watchman (control) - Watchman left atrial appendage closure device
Treatment: Devices: Coherex WaveCrest® Left Atrial Appendage Occlusion System
Percutaneous left atrial appendage closure
Treatment: Devices: Watchman® LAA Closure Device
Percutaeous left atrial appendage closure
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Procedure or device related complications
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Assessment method [1]
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Part of the composite rate of the primary safety endpoint.
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Timepoint [1]
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45 Days
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Primary outcome [2]
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All Death
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Assessment method [2]
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Part of the composite rate of the primary safety endpoint.
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Timepoint [2]
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24 months
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Primary outcome [3]
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Major Bleeding
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Assessment method [3]
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Part of the composite rate of the primary safety endpoint.
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Timepoint [3]
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24 months
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Primary outcome [4]
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Ischemic stroke, systemic embolism
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Assessment method [4]
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The primary effectiveness endpoint is a composite rate of ischemic stroke or systemic embolism at 24 months
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Timepoint [4]
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24 months
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Secondary outcome [1]
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Ischemic stroke, systemic embolism
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Assessment method [1]
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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
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Timepoint [1]
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45 days
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Eligibility
Key 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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/12/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/12/2023
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Sample size
Target
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Accrual to date
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Final
248
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Monash Health - Melbourne
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Recruitment hospital [2]
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St. Vincent's Hospital - Sydney
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment postcode(s) [2]
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2023 - Sydney
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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District of Columbia
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Florida
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Georgia
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Kentucky
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Maryland
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Michigan
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Mississippi
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New York
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Ohio
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Pennsylvania
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Texas
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United States of America
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Virginia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Coherex Medical
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Biosense Webster, Inc.
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03302494
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Vivek Reddy, MD
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Address
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MOUNT SINAI HOSPITAL
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03302494
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