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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
No Placebo-Only Group

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
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I am 18 years old or older.
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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:
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I am scheduled for heart surgery without a full chest opening.
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I have an infection needing antibiotics, including COVID-19, at the time of my heart surgery.
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I have had surgery that opened the sac around my heart.
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I have had a procedure to close or remove my left atrial appendage.
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I have an ongoing heart infection.
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I am scheduled for a heart transplant or to get a heart support device.
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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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Effectiveness Endpoint
Primary Safety Endpoint
Secondary study objectives
Powered Secondary Effectiveness endpoint

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
164 Previous Clinical Trials
712,014 Total Patients Enrolled
17 Trials studying Stroke
111,422 Patients Enrolled for 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
1 Trials studying Stroke
15,989 Patients Enrolled for Stroke

Media Library

AtriClip LAA Exclusion System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05478304 — N/A
Stroke Research Study Groups: Treatment, Control
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
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