← Back to Search

Device

Left Atrial Appendage Exclusion for Stroke Prevention (LeAAPS Trial)

N/A
Recruiting
Research Sponsored by AtriCure, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects ≥ 18 years of age
CHA2DS2-VASc ≥ 4 with age ≥ 65
Must not have
Planned cardiac surgical procedure using non-sternotomy approaches (partial sternotomies allowed)
Active systemic infection at the time of cardiac surgery requiring antibiotics, including known SARS-CoV2 infections regardless of symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up common termination point (median follow-up for 5 years)
Awards & highlights

Summary

This trialwill evaluate if excluding the left atrial appendage during cardiac surgery can prevent stroke in people at risk for atrial fibrillation.

Who is the study for?
This trial is for adults over 18 at risk of atrial fibrillation and stroke, with specific clinical criteria like a CHA2DS2-VASc score ≥4 if they're 65 or older. It's not for those with life expectancy under a year, severe symptomatic carotid disease, current enrollment in conflicting trials, pregnancy, prior LAA procedures, planned non-sternotomy cardiac surgeries, active infections including COVID-19, metal allergies to Nitinol or nickel sensitivity.
What is being tested?
The trial tests the AtriClip LAA Exclusion System's effectiveness in preventing strokes or embolisms in patients undergoing heart surgery who are at risk of atrial fibrillation. It's a prospective (forward-looking), randomized (patients assigned by chance), multicenter (multiple study locations), multinational (across countries), blinded (information withheld from participants) superiority trial.
What are the potential side effects?
While specific side effects aren't listed here, similar procedures may include risks such as bleeding complications, infection at the surgical site, general anesthesia risks and potential adverse reactions to the device material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am 65 or older with a high stroke risk score.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am scheduled for heart surgery without a full chest opening.
Select...
I have an infection needing antibiotics, including COVID-19, at the time of my heart surgery.
Select...
I have had surgery that opened the sac around my heart.
Select...
I have had a procedure to close or remove my left atrial appendage.
Select...
I have an ongoing heart infection.
Select...
I am scheduled for a heart transplant or to get a heart support device.
Select...
I have severe symptoms from carotid artery disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~common termination point (median follow-up for 5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and common termination point (median follow-up for 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Effectiveness Endpoint
Primary Safety Endpoint
Secondary outcome measures
Powered Secondary Effectiveness endpoint

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
Group II: ControlActive Control1 Intervention
No LAAE concomitant to and at the time of planned cardiac surgery

Find a Location

Who is running the clinical trial?

Population Health Research InstituteOTHER
161 Previous Clinical Trials
705,634 Total Patients Enrolled
4 Trials studying Ischemic Stroke
6,427 Patients Enrolled for Ischemic Stroke
AtriCure, Inc.Lead Sponsor
42 Previous Clinical Trials
12,271 Total Patients Enrolled
Richard Whitlock, MDStudy ChairMcMaster University
6 Previous Clinical Trials
26,159 Total Patients Enrolled

Media Library

AtriClip LAA Exclusion System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05478304 — N/A
Ischemic Stroke Research Study Groups: Treatment, Control
Ischemic Stroke Clinical Trial 2023: AtriClip LAA Exclusion System Highlights & Side Effects. Trial Name: NCT05478304 — N/A
AtriClip LAA Exclusion System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05478304 — N/A
~4333 spots leftby Dec 2031
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top