Left Atrial Appendage Closure Device for Atrial Fibrillation

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device designed to help people with atrial fibrillation, a condition where the heart beats irregularly, increasing stroke risk. The device, called the Conformal Left Atrial Appendage Seal, aims to block a small part of the heart where blood clots often form. It could be a suitable option for those with ongoing atrial fibrillation who are at high risk of stroke and seek alternatives to blood-thinning medications. Participants should be comfortable with regular follow-up visits and taking specific medications as part of the trial. As an unphased trial, this study provides an opportunity to explore innovative solutions for managing atrial fibrillation.

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 prior data suggests that this device is safe for left atrial appendage occlusion?

Research has shown that the Conformal Left Atrial Appendage Seal is safe to use. In one study, doctors successfully placed the device in 59 patients. They monitored the patients with a transesophageal echo (TEE) during the procedure, 45 days later, and again after a year. This indicates that the device is generally well-tolerated over time.

The device helps prevent strokes by sealing off a part of the heart where blood clots can form. This is particularly important for individuals with atrial fibrillation, an irregular heartbeat that can lead to blood clots. Overall, evidence suggests that the Conformal Left Atrial Appendage Seal is a safe option for patients requiring this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Conformal Left Atrial Appendage Seal (CLAAS) for atrial fibrillation because it offers a potentially safer and more efficient way to prevent strokes compared to traditional blood thinners like warfarin or newer oral anticoagulants. This device specifically targets the left atrial appendage, where clots often form in patients with atrial fibrillation, reducing the need for systemic medication. The CLAAS device is guided into place using advanced imaging techniques, which may result in more precise placement and fewer complications. This approach could be a game-changer for patients who are at high risk of bleeding or those who cannot tolerate long-term anticoagulation therapy.

What evidence suggests that this device is effective for atrial fibrillation?

Research shows that the Conformal Left Atrial Appendage Seal (CLAAS) device, which participants in this trial will receive, works well for people with atrial fibrillation, an irregular heartbeat. Studies have found that devices like this can greatly lower the risk of bleeding strokes and match blood thinners in preventing strokes caused by blockages. The CLAAS device is designed to fit various heart shapes and sizes, creating a tight seal to prevent clot formation. Early clinical experiences with CLAAS have been promising, indicating it performs well compared to other devices like WATCHMAN and Amulet. ^{1 4 6 7 8}

Who Is on the Research Team?

William Gray, MD

Principal Investigator

Main Line Health Lankenae Heart Institute

Are You a Good Fit for This Trial?

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

Your heart's left atrial appendage is not suitable for the CLAAS device according to the manufacturer's instructions.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jcin.2021.08.060

Conformal Left Atrial Appendage Seal Device for ... - JACC Percutaneous LAAC devices have been shown to significantly reduce hemorrhagic strokes and to be noninferior to OAC for ischemic strokes (7-11). On the basis of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1936879821016691

Conformal Left Atrial Appendage Seal Device for ... The authors report the first clinical experience with the Conformal Left Atrial Appendage Seal (CLAAS) device.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05147792

Study Details | NCT05147792 | The CONFORM Pivotal Trial The CLAAS device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN and Amulet ...

4. conformalmedical.com conformalmedical.com/company/news/the-claas-system-by-conformal-medical-demonstrates-sizing-simplicity-and-seal-efficiency-during-af-symposium-live-case-presentation

The CLAAS® System by Conformal Medical Demonstrates… The CLAAS implant features a nitinol endoskeleton with a proprietary foam matrix to seal a wide spectrum of LAA anatomies with only two sizes.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8213491/

Preclinical Assessment of a Novel Conformable Foam ... We present preclinical evaluations of a novel device, the Conformal Left Atrial Appendage Seal (CLAAS).

6. conformalmedical.com conformalmedical.com/company/news/conformal-medical-announces-compelling-one-year-data-from-its-left-atrial-appendage-occlusion-laao-early-feasibility-study

Conformal Medical Announces Compelling One-Year Data ... The CLAAS device was successfully implanted in 59 patients with transesophageal echo (TEE) performed intra-procedurally, at 45 days and again at ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03616028

NCT03616028 | The CONFORMAL Early Feasibility Study Study Overview. Brief Summary. An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772930322005956

Foam-based Left Atrial Appendage Closure (CLAAS) Device Conformal Left Atrial Closure System is a next-generation foam-based device. •. Chronic canine studies showed complete closure at 90 and 150 days. Abstract ...