StrokePhase 3WAVECREST2NCT03302494
WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2
A Phase 3 study testing Coherex WaveCrest® Left Atrial Appendage Occlusion System and Watchman® LAA Closure Device in people with Stroke, run by Coherex Medical at 25 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Coherex WaveCrest® Left Atrial Appendage Occlusion System and Watchman® LAA Closure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 27 Dec 2017to 21 Dec 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 34Show fewer
- 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
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States23 sites
Piedmont Heart Institute
Atlanta, Georgia, 30309
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
Northwell Health
Bay Shore, New York, 11706
Grandview Medical Center
Birmingham, Alabama, 35243
Dignity Health Mercy Gilbert Medical Center
Chandler, Arizona, 85224
Ohio State University
Columbus, Ohio, 43210
Baylor Scott & White All Saints Medical Center
Fort Worth, Texas, 76104
UPMC Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, 17104
St. Vincent's Medical Center
Jacksonville, Florida, 32204
Baptist Health Lexington
Lexington, Kentucky, 40503
Pacific Heart Institute / St. John's Health Center
Los Angeles, California, 90033
Wellstar Kennestone
Marietta, Georgia, 30060
Marquette General Hospital
Marquette, Michigan, 49855
New York University- NYU Langone Cardiac
New York, New York, 10016
New York University
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Heart Hospital Baylor Plano (Baylor Research Institute)
Plano, Texas, 75093
Virginia Commonwealth University
Richmond, Virginia, 23298
Munson Medical Center
Traverse City, Michigan, 49684
Cardiology Associates Research, LLC
Tupelo, Mississippi, 38801
Christus Trinity Clinic Research
Tyler, Texas, 75702
Medstar Heart and Vascular Institute - Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
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.
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Coherex WaveCrest® Left Atrial Appendage Occlusion System, Watchman® LAA Closure Device
- Keywords
- Non-valvular Atrial Fibrillation, Left Atrial Appendage
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coherex WaveCrest® Left Atrial Appendage Occlusion SystemDevice
Percutaneous left atrial appendage closure
Watchman® LAA Closure DeviceDevice
Percutaeous left atrial appendage closure
| Study group | Role | What they receive |
|---|---|---|
| WaveCrest | Experimental | WaveCrest left atrial appendage occluder Receives: Device: Coherex WaveCrest® Left Atrial Appendage Occlusion System |
| Watchman (control) | Active comparator | Watchman left atrial appendage closure device Receives: Device: Watchman® LAA Closure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Composite of All Cause Death, Procedure or Device Related Complications Requiring Percutaneous or Surgical Intervention or Major Bleeding
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.
Measured: 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
Percentage of Participants With Composite of Ischemic Stroke or Systemic Embolism at 24 Months
Percentage of participants with composite of ischemic stroke or systemic embolism at 24 months was reported.
Measured: At 24 months
Secondary outcomes (2)
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
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.
Measured: At 45 days
Percentage of Participants With Left Atrial Appendage (LAA) Closure
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.
Measured: At 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start27 Dec 2017
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Why it stopped: Study closed due to device design modification
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coherex Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor
- Investigators
- Vivek Reddy, MD, Study chair, MOUNT SINAI HOSPITALGregg Stone, MD, Study chair, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302494
- Sponsor's protocol ID
- CHX_IP014
- Acronym
- WAVECREST2
- Status last verified
- Mar 2025
- First submitted
- 29 Sep 2017
- Last updated
- 12 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03302494
- Acronym / sponsor ID
- WAVECREST2 / CHX_IP014
- Conditions
- Stroke
- Keywords
- Non-valvular Atrial Fibrillation, Left Atrial Appendage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed due to device design modification
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Coherex MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Biosense Webster, Inc.
- Study start
- 27 Dec 2017 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Posted 12 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WaveCrest | Experimental | Device: Coherex WaveCrest® Left Atrial Appendage Occlusion SystemWaveCrest left atrial appendage occluder |
| Watchman (control) | Active comparator | Device: Watchman® LAA Closure DeviceWatchman left atrial appendage closure device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coherex WaveCrest® Left Atrial Appendage Occlusion SystemPercutaneous left atrial appendage closure | Device | WaveCrest |
| Watchman® LAA Closure DevicePercutaeous left atrial appendage closure | Device | Watchman (control) |
Primary outcome
Percentage of Participants With Composite of All Cause Death, Procedure or Device Related Complications Requiring Percutaneous or Surgical Intervention or Major Bleeding
Time frame: 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
Time frame: At 24 months
Percentage of participants with composite of ischemic stroke or systemic embolism at 24 months was reported.
2 secondary outcomes
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
Time frame: At 45 days
Percentage of Participants With Left Atrial Appendage (LAA) Closure
Time frame: At 45 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Reddy, MD study chair
MOUNT SINAI HOSPITAL
Gregg Stone, MD study chair
MOUNT SINAI HOSPITAL
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Coherex WaveCrest® Left Atrial Appendage Occlusion System and Watchman® LAA Closure Device in people with Stroke, run by Coherex Medical at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Composite of All Cause Death, Procedure or Device Related Complications Requiring Percutaneous or Surgical Intervention or Major Bleeding (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.