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

NCT03302494 | Terminated Phase 3 Results DMC FDA Device

• 1 other identifier: CHX_IP014
• Study Type: interventional
• Target: 248
• Locations: 2 countries
• Sites: 25

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.

Conditions

Stroke

Keywords

Non-valvular Atrial Fibrillation; Left Atrial Appendage

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  At 45 days

• Percentage of Participants With Left Atrial Appendage (LAA) Closure

  At 45 days

Study Arms (2)

WaveCrest

EXPERIMENTAL

WaveCrest left atrial appendage occluder

Device: Coherex WaveCrest® Left Atrial Appendage Occlusion System

Watchman (control)

ACTIVE COMPARATOR

Watchman left atrial appendage closure device

Device: Watchman® LAA Closure Device

Interventions

Coherex WaveCrest® Left Atrial Appendage Occlusion System DEVICE

Percutaneous left atrial appendage closure

WaveCrest

Watchman® LAA Closure Device DEVICE

Percutaeous left atrial appendage closure

Watchman (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 percutaneous or surgical closure of a patent foramen ovale or atrial septal defect
• 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

Sponsors & Collaborators

• Coherex Medical: lead
• Biosense Webster, Inc.: collaborator

Study Sites (25)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

Dignity Health Mercy Gilbert Medical Center

Chandler, Arizona, 85224, United States

Location

Pacific Heart Institute / St. John's Health Center

Los Angeles, California, 90033, United States

Location

Medstar Heart and Vascular Institute - Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

St. Vincent's Medical Center

Jacksonville, Florida, 32204, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Wellstar Kennestone

Marietta, Georgia, 30060, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Marquette General Hospital

Marquette, Michigan, 49855, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Cardiology Associates Research, LLC

Tupelo, Mississippi, 38801, United States

Location

Northwell Health

Bay Shore, New York, 11706, United States

Location

New York University- NYU Langone Cardiac

New York, New York, 10016, United States

Location

New York University

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

UPMC Pinnacle Health Cardiovascular Institute

Harrisburg, Pennsylvania, 17104, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Baylor Scott & White All Saints Medical Center

Fort Worth, Texas, 76104, United States

Location

Heart Hospital Baylor Plano (Baylor Research Institute)

Plano, Texas, 75093, United States

Location

Christus Trinity Clinic Research

Tyler, Texas, 75702, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Monash Health

Melbourne, Australia

Location

St. Vincent's Hospital

Sydney, 2023, Australia

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Senior Director Clinical Research
• Organization: Coherex Medical, Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Vivek Reddy, MD

  MOUNT SINAI HOSPITAL

  STUDY CHAIR

• Gregg Stone, MD

  MOUNT SINAI HOSPITAL

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 5, 2017
• Study Start: December 27, 2017
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (23); AU (2)