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

March 5, 2025 updated by: Coherex Medical

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
248

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: At 24 months
Percentage of participants with composite of ischemic stroke or systemic embolism at 24 months was reported.
At 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
At 45 days
Percentage of Participants With Left Atrial Appendage (LAA) Closure
Time Frame: At 45 days
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.
At 45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Coherex Medical

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biosense Webster, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Vivek Reddy, MD, Mount Sinai Hospital
  • Study Chair: Gregg Stone, MD, Mount Sinai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHX_IP014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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