Left Atrial Appendage Exclusion for Stroke Prevention

(LeAAPS Trial)

Not currently recruiting at 153 trial locations

Overseen By Anson Lee, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AtriCure, Inc.

Disqualifiers: Atrial fibrillation, Heart transplant, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Immediate (during surgery)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a specific procedure, left atrial appendage exclusion (LAAE) using the AtriClip LAA Exclusion System, can prevent strokes in individuals undergoing heart surgery who have risk factors for atrial fibrillation (irregular heartbeat) and ischemic stroke. The trial compares two groups: one receiving the LAAE procedure during surgery and one without it. Participants should have existing heart issues and be at risk for strokes, but must not have a history of certain heart conditions like atrial fibrillation or previous heart surgeries. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially benefit future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that the AtriClip LAA Exclusion System is safe for stroke prevention?

Research has shown that the AtriClip Left Atrial Appendage (LAA) Exclusion System is generally well-tolerated by patients. One study found that patients using the AtriClip to prevent strokes had good results and experienced few side effects. In similar procedures, the AtriClip effectively prevented strokes in patients not on blood thinners.

The AtriClip is also used for patients at high risk of blood clots, indicating it has undergone safety testing in these situations. Follow-up data from other studies show that this device performs well over time, with few complications. Overall, these findings suggest that the AtriClip is a safe option for blocking the left atrial appendage to help prevent strokes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AtriClip LAA Exclusion System for stroke prevention because it offers a unique approach compared to standard treatments like anticoagulant medications. Unlike these medications, which work by thinning the blood to prevent clots, the AtriClip physically closes off the left atrial appendage, where clots often form. This mechanical method potentially reduces the risk of bleeding complications associated with long-term use of blood thinners. By addressing stroke risk directly at its source, the AtriClip provides a promising alternative for patients undergoing cardiac surgery.

What evidence suggests that the AtriClip LAA Exclusion System is effective for stroke prevention?

In this trial, participants will either receive the AtriClip Left Atrial Appendage Exclusion System or undergo planned cardiac surgery without the exclusion procedure. Research has shown that the AtriClip System effectively prevents strokes. One study found that the procedure successfully closed the left atrial appendage (a small pouch in the heart) in 97.8% of patients, which is crucial for reducing stroke risk. No device-related side effects were reported, indicating safety. Another review highlights that closing the left atrial appendage helps prevent strokes in people with atrial fibrillation (a heart rhythm disorder). Long-term follow-up data also support its effectiveness in preventing strokes, even for those not taking blood thinners. ^{2 3 4 6 7}

Who Is on the Research Team?

Richard Whitlock, MD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have a high stroke risk due to my CHA2DS2-VASc score, age, heart size, or NT-proBNP levels.

I am 65 or older with a high stroke risk score.

I'm sorry, but the criterion you provided is incomplete. It seems to be a heading for a list of clinical criteria. If you can provide the specific clinical criteria, I'd be happy to help simplify them.

Exclusion Criteria

You are allergic to Nitinol or nickel.

Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial

I am scheduled for heart surgery without a full chest opening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo left atrial appendage exclusion (LAAE) or no LAAE concomitant to planned cardiac surgery

Immediate (during surgery)

1 visit (in-person, during surgery)

Follow-up

Participants are monitored for safety and effectiveness after the index procedure

30 days

1 visit (in-person)

Long-term follow-up

Participants are monitored for the occurrence of ischemic stroke or systemic arterial embolism

5 years

What Are the Treatments Tested in This Trial?

Interventions

• AtriClip LAA Exclusion System

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery

Group II: Control Active Control 1 Intervention

No LAAE concomitant to and at the time of planned cardiac surgery

AtriClip LAA Exclusion System is already approved in United States, European Union for the following indications:

Approved in United States as AtriClip Left Atrial Appendage Exclusion System for:

• Stroke prevention in patients undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke

Approved in European Union as AtriClip Left Atrial Appendage Exclusion System for:

• Stroke prevention in patients undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke

Who Is Running the Clinical Trial?

AtriCure, Inc.

Lead Sponsor

Trials

43

Recruited

22,800+

Population Health Research Institute

Collaborator

Trials

165

Recruited

717,000+

Published Research Related to This Trial

The study demonstrated that left atrial appendage (LAA) ligation using a natural orifice transluminal endoscopic surgery (NOTES) approach is feasible and safe in an animal model, with no adverse events reported during the survival period.

The procedure was successfully completed in all but one of the pigs, with an average ligation time of 34.4 minutes, suggesting that this method could serve as an alternative to long-term anticoagulant therapy for high-risk patients with atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left atrial appendage ligation with single transthoracic port assistance: a study of survival assessment in a porcine model (with videos). Moreira-Pinto, J., Ferreira, A., Miranda, A., et al.[2012]

The AtriClip device successfully occluded the left atrial appendage (LAA) in all 43 patients studied, with a mean follow-up of 7.1 years, confirming its efficacy in preventing blood flow in the excluded LAA.

While 72% of patients had no residual stump, 26% had small stumps (<10 mm), and only 2% had a significant stump (>10 mm), suggesting that the AtriClip has a favorable occlusion profile, though the clinical implications of small stumps need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and characteristics of left atrial appendage stumps after device-enabled epicardial closure. Caliskan, E., Eberhard, M., Falk, V., et al.[2020]

The AtriClip PRO·V device (AOD2) was successfully tested in a canine model, showing easy and reliable exclusion of the left atrial appendage without complications over a 90-day period.

All devices demonstrated effective occlusion of the atrial appendages and acceptable biocompatibility, suggesting that AOD2 could be a promising option for reducing stroke risk in patients with atrial fibrillation once approved for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a refined advanced design for left atrial appendage exclusion. Sunagawa, G., Karimov, JH., Breitbach, M., et al.[2018]

In a study of 25 patients undergoing left atrial appendage closure (LAAC) for stroke prevention, 48% showed acute brain lesions immediately after the procedure, but 71% of those lesions were no longer detectable after three months.

Neurocognitive function, assessed using the MoCA test and NIHSS score, showed no significant changes immediately after LAAC or at the three-month follow-up, suggesting that LAAC does not adversely affect cognitive abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow up of 3 T MRI-detected brain lesions after percutaneous catheter-based left atrial appendage closure. Bellmann, B., Rillig, A., Skurk, C., et al.[2019]

Left atrial appendage exclusion using the AtriClip is an effective alternative to anticoagulation therapy for reducing stroke risk in patients with atrial fibrillation.

The article discusses important aspects of the procedure and the necessary post-procedural management to ensure patient safety and efficacy of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left Atrial Appendage Epicardial Clip (AtriClip): Essentials and Post-Procedure Management. Bedeir, K., Warriner, S., Kofsky, E., et al.[2020]

The novel atrial exclusion device was successfully implanted in 15 dogs, demonstrating safe and effective exclusion of the left atrial appendage without causing hemodynamic instability, evaluated over a period of up to 6 months.

Histological analysis showed the development of a new endothelial tissue layer at the occluded site, indicating promising biological integration and potential for reducing stroke risk in patients with atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left atrial appendage occlusion: pilot study of a fourth-generation, minimally invasive device. Fumoto, H., Gillinov, AM., Saraiva, RM., et al.[2016]

In a study of 75 high-risk atrial fibrillation patients, left atrial appendage closure (LAAC) significantly reduced bleeding events and major bleeds after the procedure, leading to a decrease from 1.8 to 0.6 bleeding events per year (p < 0.0001).

LAAC also resulted in a significant increase in serum hemoglobin levels from 9.9 to 11.9 g/dL (p = 0.0005) and reduced the incidence of strokes from 14 before the procedure to 3 after (p = 0.008), demonstrating its efficacy as a stroke prevention strategy for patients intolerant to oral anticoagulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Less major bleeding and higher hemoglobin after left atrial appendage closure in high-risk patients: Data from a long-term, longitudinal, two-center observational study. Schach, C., Reitschuster, R., Benedikt, D., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31292605/

Outcomes of left atrial appendage occlusion using the ... LAA occlusion was achieved in 902 out of 922 patients (97.8%). No device-related adverse events were reported across the studies. The reported ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.121.022274

Left Atrial Appendage Occlusion for Stroke Prevention in ... We present a contemporary review of left atrial appendage occlusion for stroke prevention in nonvalvular atrial fibrillation.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02701062

NCT02701062 | AtriClip® Left Atrial Appendage Exclusion ... Subjects who develop Post-operative Atrial Fibrillation (POAF) and receive the AtriClip will be followed for 365 days post index procedure. Detailed Description.

4. ir.atricure.com ir.atricure.com/news-releases/news-release-details/atricure-completes-enrollment-leaaps-clinical-trial-stroke

AtriCure Completes Enrollment in LeAAPS Clinical Trial for ... This landmark trial evaluates the stroke reduction benefit with AtriClip devices for the over one million cardiac surgery patients globally without a ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6652788/

Left Atrial Appendage Epicardial Clip (AtriClip) Also, the 45 months follow-up data from the PROTECT AF trial demonstrate the efficacy of LAA exclusion in preventing strokes in patients not on anticoagulation.

6. atricure.com atricure.com/healthcare-professionals/therapies/LAAM

Left Atrial Appendage Management - AtriClip Device This exclusion eliminates blood flow and electrical communication of blood between the left atrium (LA) and the LAA and results in the electrical isolation of ...

7. europe.atricure.com europe.atricure.com/sites/default/files/devices-ifu/CEM-266.B_en_English.pdf

Summary of Safety and Clinical Performance (SSCP) ... The AtriClip LAA Exclusion System is indicated for use in patients at high risk of thromboembolism for whom left atrial appendage exclusion is ...