Left Atrial Appendage Closure Device for Atrial Fibrillation

Recruiting at 12 trial locations

Overseen By Andrea Natale, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Conformal Medical, Inc

Must be taking: Oral anticoagulants

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Pregnancy, Severe heart failure, Stroke, others

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

Compensation: Varies

Number of Visits: 6

Duration: 1 day

64 Participants Needed

Trial Summary

What is the purpose of this trial?

An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be willing to follow the study's medication plan, which may involve changes to your current regimen.

What data supports the effectiveness of the Conformal Left Atrial Appendage Seal treatment for atrial fibrillation?

The Conformal Left Atrial Appendage Seal (CLAAS) device has been evaluated in preclinical studies, showing promise as an alternative to blood thinners for preventing strokes in patients with atrial fibrillation. Initial clinical experiences with the device have been reported, suggesting it may be effective for left atrial appendage closure. ^{1 2 3 4 5}

Is the Conformal Left Atrial Appendage Seal device safe for humans?

The Conformal Left Atrial Appendage Seal (CLAAS) device has been evaluated in preclinical studies and has been used in clinical settings, but specific long-term safety data for this device is not detailed in the available research. Other similar devices for left atrial appendage closure, like the Amplatzer Cardiac Plug and the LAmbre device, have been studied for safety in patients with atrial fibrillation. ^{1 2 3 6 7}

How is the Conformal Left Atrial Appendage Seal treatment different from other treatments for atrial fibrillation?

The Conformal Left Atrial Appendage Seal (CLAAS) is unique because it uses a novel foam-based design to close the left atrial appendage, which may offer a more adaptable fit compared to other devices. This could potentially address limitations of current devices and improve the success of the procedure for patients who cannot take blood thinners. ^{1 2 8 9 10}

Research Team

William Gray, MD

Principal Investigator

Main Line Health Lankenae Heart Institute

Eligibility Criteria

Adults with non-valvular atrial fibrillation who need but want to avoid long-term oral anticoagulation therapy. Candidates should have a CHA2DS2-VASc score of ≥2 for men or ≥3 for women, indicating a higher risk of stroke. They must be able to follow the study's procedures and provide consent. Exclusions include pregnancy, certain heart conditions, other investigational studies participation, life expectancy under 2 years, severe kidney issues, and allergies to specific medications or device materials.

Inclusion Criteria

I have a type of irregular heartbeat not caused by a heart valve issue.

I am at high risk for stroke, with a CHA2DS2-VASc score of 2 or more (men) or 3 or more (women).

I am advised to take blood thinners but need a non-drug alternative.

Exclusion Criteria

I am not pregnant or nursing and do not plan to become pregnant within a year.

Current participation in another investigational drug or device study

I am allergic to aspirin, heparin, nickel, titanium, gold, or certain medications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Left atrial appendage closure (LAAC) with the CLAAS device will be performed according to the device Instructions for Use, based on TEE, ICE and angiographic guidance, femoral venous access and inter-atrial septum crossing.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Multiple visits over 5 years

Treatment Details

Interventions

• Conformal Left Atrial Appendage Seal

Trial Overview The trial is testing the safety and effectiveness of the Conformal Left Atrial Appendage Seal (CLAAS) as an alternative to chronic oral anticoagulation in preventing stroke in patients with atrial fibrillation. It involves implanting CLAAS via catheter-based system.

Participant Groups

Group I: Non-valvular AF adults Experimental Treatment 1 Intervention

Left atrial appendage closure (LAAC) with the CLAAS device will be performed according to the device Instructions for Use, based on TEE, ICE and angiographic guidance, femoral venous access and inter-atrial septum crossing.

Who Is Running the Clinical Trial?

Conformal Medical, Inc

Lead Sponsor

Trials

5

Recruited

2,100+

Yale Cardiovascular Research Group

Collaborator

Trials

11

Recruited

4,000+

Findings from Research

The CLAAS device, designed for left atrial appendage closure, was successfully implanted in 18 out of 22 patients with high stroke risk, demonstrating its clinical feasibility without serious procedural complications.

Follow-up at 45 days revealed only one significant leak and one device-related thrombus, both manageable, indicating that the CLAAS device is a safe option for patients with atrial fibrillation who require stroke prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conformal Left Atrial Appendage Seal Device for Left Atrial Appendage Closure: First Clinical Use. Sommer, RJ., Kim, JH., Szerlip, M., et al.[2022]

The Conformal Left Atrial Appendage Seal (CLAAS) device showed superior conformability in preclinical tests, effectively sealing various oval orifice sizes without gaps, unlike the Watchman 2.5 device.

In canine studies, the CLAAS implant achieved complete sealing of the left atrial appendage with no thrombus formation and demonstrated minimal inflammation after 60 days, indicating its potential safety and efficacy for stroke prevention in atrial fibrillation patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical Assessment of a Novel Conformable Foam-Based Left Atrial Appendage Closure Device. Sommer, RJ., Lamport, R., Melanson, D., et al.[2022]

References

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

Conformal Left Atrial Appendage Seal Device for Left Atrial Appendage Closure: First Clinical Use. [2022]

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

Preclinical Assessment of a Novel Conformable Foam-Based Left Atrial Appendage Closure Device. [2022]

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

Long-Term Safety and Efficacy in Continued Access Left Atrial Appendage Closure Registries. [2020]

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

Adverse Events After Left Atrial Appendage Closure: Lessons Learned From the Manufacturer and User Facility Device Experience (MAUDE) Database. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Epicardial left atrial appendage occlusion with a new medical device: assessment of procedural feasibility, safety and efficacy in a large animal model. [2020]

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

Safety of percutaneous left atrial appendage closure with the Amplatzer cardiac plug in patients with atrial fibrillation and contraindications to anticoagulation. [2017]

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

Long-Term Safety and Efficacy of Percutaneous Left Atrial Appendage Closure with the LAmbre Device. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Device- and LAA-Specific Characteristics for Successful LAA Closure: Tips and Tricks. [2019]

9. Spain pubmed.ncbi.nlm.nih.gov

Immediate and one-year results in 35 consecutive patients after closure of left atrial appendage with the Amplatzer cardiac plug. [2019]

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

Endocardial versus epicardial left atrial appendage exclusion for stroke prevention in patients with atrial fibrillation: Midterm follow-up. [2021]