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LAA Occlusion Device
WaveCrest vs. Watchman Devices for Stroke Prevention (WAVECREST2 Trial)
Phase 3
Waitlist Available
Research Sponsored by Coherex Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation
At least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
WAVECREST2 Trial Summary
This trial is testing a new device to prevent strokes. The device is placed in the heart to block the left atrial appendage, which is where strokes often happen.
Who is the study for?
This trial is for adults with non-valvular atrial fibrillation who have a moderate to high stroke risk (CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3), need an alternative to long-term warfarin therapy, and can follow the post-implant drug regimen. Excluded are those with recent strokes, certain heart conditions, severe kidney issues, planned surgeries, or other health problems that could affect participation.Check my eligibility
What is being tested?
The WAVECREST 2 trial compares two devices designed to prevent strokes in people with atrial fibrillation: the Coherex WaveCrest Left Atrial Appendage Occlusion System and the Watchman LAA Closure Device. Participants will be randomly assigned one of these treatments.See study design
What are the potential side effects?
Potential side effects may include complications from catheterization procedures like bleeding or infection, allergic reactions to device materials such as nickel, blood clots forming on the device leading to stroke risks, and possible need for future interventions if complications arise.
WAVECREST2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a type of irregular heartbeat not caused by a heart valve issue.
Select...
I am 18 years old or older.
WAVECREST2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All Death
Major Bleeding
Procedure or device related complications
Secondary outcome measures
Ischemic stroke, systemic embolism
WAVECREST2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: WaveCrestExperimental Treatment1 Intervention
WaveCrest left atrial appendage occluder
Group II: Watchman (control)Active Control1 Intervention
Watchman left atrial appendage closure device
Find a Location
Who is running the clinical trial?
Biosense Webster, Inc.Industry Sponsor
122 Previous Clinical Trials
36,339 Total Patients Enrolled
Coherex MedicalLead Sponsor
4 Previous Clinical Trials
216 Total Patients Enrolled
Vivek Reddy, MDStudy ChairMOUNT SINAI HOSPITAL
33 Previous Clinical Trials
11,048 Total Patients Enrolled
2 Trials studying Stroke
3,131 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a heart transplant, mitral valve replacement, or any type of mechanical heart valve implant.I need help with my daily activities due to my condition.I am allergic to warfarin, nickel, aspirin, IV contrast, or certain blood thinners and cannot be treated for these allergies.I need an alternative to long-term blood thinner pills.I need long-term blood thinners for a condition other than atrial fibrillation.I have had surgery or a device implanted to close off the left atrial appendage in my heart.There are signs of a blood clot inside the heart.I have a type of irregular heartbeat not caused by a heart valve issue.This criterion refers to specific conditions that would prevent someone from participating in the study based on the results of an echocardiogram, which is a test that uses sound waves to create a moving picture of the heart.I have not had a heart attack in the last 60 days.I haven't had any major surgeries or heart procedures in the last 30 days.I have a significant or symptomatic fluid buildup around my heart.I have the most severe form of heart failure.I haven't taken oral antibiotics in the last 14 days or IV antibiotics in the last 30 days.I am on dialysis or have severe kidney issues.I am not pregnant nor planning to become pregnant during the trial.My heart's mitral valve is narrowed or deformed, likely due to rheumatic disease.You have a buildup of plaque in certain parts of your aorta.Your heart's left atrial appendage is not the right size or shape for using a WaveCrest or Watchman device.I am 18 years old or older.I cannot or will not take blood thinners for 45 days after my procedure.I have had a stroke or a mini-stroke in the last 2 months.Your calculated CHADS2 score is 2 or higher, or your CHA2DS2-VASc score is 3 or higher.You have a medical condition that is expected to shorten your life to less than 2 years.I have a tumor in my heart.My heart's aortic valve is narrowed.I have had surgery to close a hole in my heart.Your heart rate is consistently very high, even when you are not active.Your blood work shows low platelets, white blood cells, or hemoglobin within the last 30 days.I have had heart surgery or interventions for birth defects.My atrial fibrillation is caused by a temporary condition.I have a heart condition that requires closing a hole in my heart.Your heart is not pumping enough blood.I have had a blocked artery in my neck or brain without surgery, but no symptoms for over 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Watchman (control)
- Group 2: WaveCrest
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At how many facilities is this clinical trial being conducted?
"There are a total of 23 clinical trial sites currently running this study. Some notable locations include: Pacific Heart Institute / St. John's Health Center in Los Angeles, Dignity Health Mercy Gilbert Medical Center in Chandler, and Wellstar Kennestone in Marietta."
Answered by AI
Are there any remaining vacancies in this clinical trial for potential participants?
"No, this study is not presently seeking patients for clinical trials. The last update on clinicaltrials.gov was on October 3rd, 2022. There are, however, 1071 other trials that are still looking for candidates."
Answered by AI
Does the Coherex WaveCrest® Left Atrial Appendage Occlusion System have any lasting side effects?
"The Coherex WaveCrest® Left Atrial Appendage Occlusion System is a phase 3 medical device, so it has received a score of 3 for safety. This is because there is some data supporting efficacy and multiple rounds of data supporting safety."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Dignity Health Mercy Gilbert Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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