Left Atrial Appendage Exclusion for Stroke Prevention

(LeAAPS Trial)

Recruiting at 128 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)

6500 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.

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 data supports the effectiveness of the treatment AtriClip LAA Exclusion System for stroke prevention?

Research shows that the AtriClip device is highly successful in excluding the left atrial appendage, which is an alternative to blood-thinning medications for reducing stroke risk in patients with atrial fibrillation (irregular heartbeat). ^{1 2 3 4 5}

How is the AtriClip LAA Exclusion System treatment different from other stroke prevention treatments?

The AtriClip LAA Exclusion System is unique because it physically closes off the left atrial appendage (a small pouch in the heart) to prevent blood clots, offering an alternative to blood-thinning medications for stroke prevention in patients with atrial fibrillation. ^{1 2 3 6 7}

Research Team

Richard Whitlock, MD

Principal Investigator

McMaster University

Eligibility Criteria

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 18 years old or older.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Left Atrial Appendage Epicardial Clip (AtriClip): Essentials and Post-Procedure Management. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Incidence and characteristics of left atrial appendage stumps after device-enabled epicardial closure. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Impact of a refined advanced design for left atrial appendage exclusion. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term follow up of 3 T MRI-detected brain lesions after percutaneous catheter-based left atrial appendage closure. [2019]

5. United States 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Left atrial appendage occlusion: pilot study of a fourth-generation, minimally invasive device. [2016]

7. United States 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). [2012]